{
    "info": {
        "nct_id": "NCT04403620",
        "official_title": "HYPORT: A Phase I/II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Squamous Cell Carcinoma",
        "inclusion_criteria": "Inclusion criteria will be the same for Phase I and Phase II.\n\n1. Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx status post gross total resection with pathology showing one or more of the following intermediate risk factors:\n\n   * T3/4 disease (AJCC 8th edition), positive lymph node(s), close margin(s), perineural invasion, and/or lymphovascular invasion\n   * Close margin(s) defined as either:\n\n     * Final patient margin of <5 mm without disease on ink OR\n     * Initial positive margin in the specimen regardless of the final patient margin (e.g. if resection margin on the initial specimen is positive, final patient margin after subsequent resections can be ≥5 mm and still be considered close margin)\n2. Age ≥18 years\n3. ECOG performance status 0-2\n4. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.\n\n   Medically acceptable birth control (contraceptives) includes:\n   * approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), or\n   * barrier methods (such as condom or diaphragm) used with a spermicide\n\n   Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\n   A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n   * Has not undergone a hysterectomy or bilateral oophorectomy; or\n   * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n5. Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.\n6. Ability to understand and the willingness to sign a written informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Phase I:\n\n1. Distant metastasis\n2. Stage I and II glottic squamous cell carcinoma\n3. High risk factors following surgical resection requiring concurrent chemotherapy: final positive margin(s) and/or extranodal extension\n4. Feeding tube dependence at baseline assessment.\n5. Synchronous non-skin cancer primaries outside of the oropharynx, oral cavity, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer. For prostate cancer, patient should not be receiving active treatment. For thyroid cancer, thyroid surgery may occur before or after treatment, provided all other eligibility criteria are met.\n6. Prior invasive malignancy with an expected disease-free interval of less than 3 years\n7. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields\n8. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements\n10. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n11. History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant\n\nPhase II:\n\nThe exclusion criteria will be the same as Phase I except for feeding tube dependence. Patients who are feeding tube dependent are excluded from Phase I to accurately assess treatment associated toxicity affecting swallowing and oral intake. During Phase II, patients who are feeding tube dependent will be eligible to enroll and stratified at randomization.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Inclusion criteria will be the same for Phase I and Phase II.",
                "criterions": [
                    {
                        "exact_snippets": "Inclusion criteria ... same for Phase I and Phase II.",
                        "criterion": "inclusion criteria",
                        "requirement": {
                            "requirement_type": "consistency",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Inclusion criteria ... same for Phase I and Phase II.",
                        "criterion": "inclusion criteria",
                        "requirement": {
                            "requirement_type": "consistency",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx status post gross total resection with pathology showing one or more of the following intermediate risk factors:",
                "criterions": [
                    {
                        "exact_snippets": "Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx",
                        "criterion": "squamous cell carcinoma",
                        "requirement": {
                            "requirement_type": "diagnosis",
                            "expected_value": "pathologically proven"
                        }
                    },
                    {
                        "exact_snippets": "Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx",
                        "criterion": "squamous cell carcinoma",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "B"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx",
                        "criterion": "squamous cell carcinoma",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "oral cavity",
                                "oropharynx",
                                "hypopharynx",
                                "larynx"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "status post gross total resection",
                        "criterion": "gross total resection",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx",
                                "criterion": "squamous cell carcinoma",
                                "requirement": {
                                    "requirement_type": "diagnosis",
                                    "expected_value": "pathologically proven"
                                }
                            },
                            {
                                "exact_snippets": "Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx",
                                "criterion": "squamous cell carcinoma",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "N/A"
                                            },
                                            {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "B"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Pathologically proven diagnosis of stage I-IVB squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx",
                                "criterion": "squamous cell carcinoma",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": [
                                        "oral cavity",
                                        "oropharynx",
                                        "hypopharynx",
                                        "larynx"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "status post gross total resection",
                        "criterion": "gross total resection",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* T3/4 disease (AJCC 8th edition), positive lymph node(s), close margin(s), perineural invasion, and/or lymphovascular invasion",
                "criterions": [
                    {
                        "exact_snippets": "T3/4 disease (AJCC 8th edition)",
                        "criterion": "disease stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T3",
                                "T4"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "positive lymph node(s)",
                        "criterion": "lymph node status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "close margin(s)",
                        "criterion": "surgical margin status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "close"
                        }
                    },
                    {
                        "exact_snippets": "perineural invasion",
                        "criterion": "perineural invasion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "lymphovascular invasion",
                        "criterion": "lymphovascular invasion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "T3/4 disease (AJCC 8th edition)",
                                "criterion": "disease stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "T3",
                                        "T4"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "positive lymph node(s)",
                                "criterion": "lymph node status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "positive"
                                }
                            },
                            {
                                "exact_snippets": "close margin(s)",
                                "criterion": "surgical margin status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "close"
                                }
                            },
                            {
                                "exact_snippets": "perineural invasion",
                                "criterion": "perineural invasion",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "lymphovascular invasion",
                                "criterion": "lymphovascular invasion",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "T3/4 disease (AJCC 8th edition)",
                                "criterion": "disease stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "T3",
                                        "T4"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "positive lymph node(s)",
                                "criterion": "lymph node status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "positive"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "T3/4 disease (AJCC 8th edition)",
                                "criterion": "disease stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "T3",
                                        "T4"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "close margin(s)",
                                "criterion": "surgical margin status",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "close"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "T3/4 disease (AJCC 8th edition)",
                                "criterion": "disease stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "T3",
                                        "T4"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "perineural invasion",
                                "criterion": "perineural invasion",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "T3/4 disease (AJCC 8th edition)",
                                "criterion": "disease stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "T3",
                                        "T4"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "lymphovascular invasion",
                                "criterion": "lymphovascular invasion",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "positive lymph node(s)",
                        "criterion": "lymph node status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "close margin(s)",
                        "criterion": "surgical margin status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "close"
                        }
                    },
                    {
                        "exact_snippets": "perineural invasion",
                        "criterion": "perineural invasion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "lymphovascular invasion",
                        "criterion": "lymphovascular invasion",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Close margin(s) defined as either:",
                "criterions": [
                    {
                        "exact_snippets": "Close margin(s)",
                        "criterion": "close margin",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "either"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Close margin(s)",
                        "criterion": "close margin",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "either"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Final patient margin of <5 mm without disease on ink OR",
                "criterions": [
                    {
                        "exact_snippets": "Final patient margin of <5 mm",
                        "criterion": "patient margin",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "without disease on ink",
                        "criterion": "disease on ink",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Final patient margin of <5 mm",
                                "criterion": "patient margin",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "mm"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "without disease on ink",
                                "criterion": "disease on ink",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Initial positive margin in the specimen regardless of the final patient margin (e.g. if resection margin on the initial specimen is positive, final patient margin after subsequent resections can be ≥5 mm and still be considered close margin)",
                "criterions": [
                    {
                        "exact_snippets": "Initial positive margin in the specimen",
                        "criterion": "initial margin status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "final patient margin ... can be ≥5 mm",
                        "criterion": "final patient margin",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Initial positive margin in the specimen",
                    "criterion": "initial margin status",
                    "requirement": {
                        "requirement_type": "status",
                        "expected_value": "positive"
                    }
                },
                "then_criteria": {
                    "exact_snippets": "final patient margin ... can be ≥5 mm",
                    "criterion": "final patient margin",
                    "requirement": {
                        "requirement_type": "size",
                        "expected_value": {
                            "operator": ">=",
                            "value": 5,
                            "unit": "mm"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "2. Age ≥18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. ECOG performance status 0-2",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status 0-2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Women of child-bearing potential",
                        "criterion": "women of child-bearing potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "men must agree to use adequate contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate contraception (hormonal or barrier method of birth control; abstinence)",
                        "criterion": "contraception method",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "hormonal",
                                "barrier method of birth control",
                                "abstinence"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "prior to study entry, for the duration of study participation, and for 90 days following completion of therapy",
                        "criterion": "contraception duration",
                        "requirement": {
                            "requirement_type": "time period",
                            "expected_value": "prior to study entry, for the duration of study participation, and for 90 days following completion of therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Women of child-bearing potential",
                                "criterion": "women of child-bearing potential",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "men must agree to use adequate contraception",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            }
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                    },
                    {
                        "exact_snippets": "adequate contraception (hormonal or barrier method of birth control; abstinence)",
                        "criterion": "contraception method",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "hormonal",
                                "barrier method of birth control",
                                "abstinence"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "prior to study entry, for the duration of study participation, and for 90 days following completion of therapy",
                        "criterion": "contraception duration",
                        "requirement": {
                            "requirement_type": "time period",
                            "expected_value": "prior to study entry, for the duration of study participation, and for 90 days following completion of therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Medically acceptable birth control (contraceptives) includes:",
                "criterions": [
                    {
                        "exact_snippets": "Medically acceptable birth control (contraceptives)",
                        "criterion": "birth control",
                        "requirement": {
                            "requirement_type": "acceptability",
                            "expected_value": "medically acceptable"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Medically acceptable birth control (contraceptives)",
                        "criterion": "birth control",
                        "requirement": {
                            "requirement_type": "acceptability",
                            "expected_value": "medically acceptable"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon), or",
                "criterions": [
                    {
                        "exact_snippets": "approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon)",
                        "criterion": "hormonal contraceptive use",
                        "requirement": {
                            "requirement_type": "approval status",
                            "expected_value": "approved"
                        }
                    },
                    {
                        "exact_snippets": "approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon)",
                        "criterion": "hormonal contraceptive use",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "birth control pills",
                                "patch",
                                "ring",
                                "Depo-Provera",
                                "Implanon"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon)",
                                "criterion": "hormonal contraceptive use",
                                "requirement": {
                                    "requirement_type": "approval status",
                                    "expected_value": "approved"
                                }
                            },
                            {
                                "exact_snippets": "approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Implanon)",
                                "criterion": "hormonal contraceptive use",
                                "requirement": {
                                    "requirement_type": "examples",
                                    "expected_value": [
                                        "birth control pills",
                                        "patch",
                                        "ring",
                                        "Depo-Provera",
                                        "Implanon"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* barrier methods (such as condom or diaphragm) used with a spermicide",
                "criterions": [
                    {
                        "exact_snippets": "barrier methods (such as condom or diaphragm) used with a spermicide",
                        "criterion": "barrier methods",
                        "requirement": {
                            "requirement_type": "examples",
                            "expected_value": [
                                "condom",
                                "diaphragm"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "barrier methods (such as condom or diaphragm) used with a spermicide",
                        "criterion": "barrier methods",
                        "requirement": {
                            "requirement_type": "used with",
                            "expected_value": "spermicide"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "barrier methods (such as condom or diaphragm) used with a spermicide",
                        "criterion": "barrier methods",
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                            "requirement_type": "examples",
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                                "condom",
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                            ]
                        }
                    },
                    {
                        "exact_snippets": "barrier methods (such as condom or diaphragm) used with a spermicide",
                        "criterion": "barrier methods",
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                            "requirement_type": "used with",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.",
                "criterions": [
                    {
                        "exact_snippets": "Should a woman become pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "suspect she is pregnant",
                        "criterion": "suspected pregnancy",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Should a woman become pregnant",
                        "criterion": "pregnancy",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "suspect she is pregnant",
                        "criterion": "suspected pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:",
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                    {
                        "exact_snippets": "female",
                        "criterion": "gender",
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                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "child-bearing potential",
                        "criterion": "child-bearing potential",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "child-bearing potential",
                        "criterion": "child-bearing potential",
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                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has not undergone a hysterectomy or bilateral oophorectomy; or",
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                    {
                        "exact_snippets": "Has not undergone a hysterectomy",
                        "criterion": "hysterectomy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "bilateral oophorectomy",
                        "criterion": "bilateral oophorectomy",
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                            "requirement_type": "presence",
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                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Has not undergone a hysterectomy",
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                            "requirement_type": "presence",
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                        }
                    },
                    {
                        "exact_snippets": "bilateral oophorectomy",
                        "criterion": "bilateral oophorectomy",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).",
                "criterions": [
                    {
                        "exact_snippets": "Has not been naturally postmenopausal for at least 12 consecutive months",
                        "criterion": "postmenopausal status",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "has had menses at any time in the preceding 12 consecutive months",
                        "criterion": "menstrual cycle",
                        "requirement": {
                            "requirement_type": "occurrence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has not been naturally postmenopausal for at least 12 consecutive months",
                        "criterion": "postmenopausal status",
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                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "has had menses at any time in the preceding 12 consecutive months",
                        "criterion": "menstrual cycle",
                        "requirement": {
                            "requirement_type": "occurrence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.",
                "criterions": [
                    {
                        "exact_snippets": "Negative serum or urine pregnancy test",
                        "criterion": "pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "within 2 weeks before registration",
                        "criterion": "timing of pregnancy test",
                        "requirement": {
                            "requirement_type": "time frame",
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                        }
                    },
                    {
                        "exact_snippets": "for women of childbearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "applicability",
                            "expected_value": "women of childbearing potential"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "for women of childbearing potential",
                    "criterion": "gender and reproductive status",
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                        "requirement_type": "applicability",
                        "expected_value": "women of childbearing potential"
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Negative serum or urine pregnancy test",
                            "criterion": "pregnancy test",
                            "requirement": {
                                "requirement_type": "result",
                                "expected_value": "negative"
                            }
                        },
                        {
                            "exact_snippets": "within 2 weeks before registration",
                            "criterion": "timing of pregnancy test",
                            "requirement": {
                                "requirement_type": "time frame",
                                "expected_value": "within 2 weeks before registration"
                            }
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "6. Ability to understand and the willingness to sign a written informed consent",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Distant metastasis",
                "criterions": [
                    {
                        "exact_snippets": "Distant metastasis",
                        "criterion": "distant metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Distant metastasis",
                    "criterion": "distant metastasis",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Stage I and II glottic squamous cell carcinoma",
                "criterions": [
                    {
                        "exact_snippets": "Stage I and II glottic squamous cell carcinoma",
                        "criterion": "glottic squamous cell carcinoma",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stage I and II glottic squamous cell carcinoma",
                        "criterion": "glottic squamous cell carcinoma",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. High risk factors following surgical resection requiring concurrent chemotherapy: final positive margin(s) and/or extranodal extension",
                "criterions": [
                    {
                        "exact_snippets": "final positive margin(s)",
                        "criterion": "surgical resection margin",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "extranodal extension",
                        "criterion": "extranodal extension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "final positive margin(s)",
                                    "criterion": "surgical resection margin",
                                    "requirement": {
                                        "requirement_type": "status",
                                        "expected_value": "positive"
                                    }
                                },
                                {
                                    "exact_snippets": "extranodal extension",
                                    "criterion": "extranodal extension",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            ]
                        },
                        "then_criteria": null,
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Feeding tube dependence at baseline assessment.",
                "criterions": [
                    {
                        "exact_snippets": "Feeding tube dependence",
                        "criterion": "feeding tube dependence",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Feeding tube dependence",
                    "criterion": "feeding tube dependence",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Prior invasive malignancy with an expected disease-free interval of less than 3 years",
                "criterions": [
                    {
                        "exact_snippets": "Prior invasive malignancy",
                        "criterion": "prior invasive malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "expected disease-free interval of less than 3 years",
                        "criterion": "disease-free interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior invasive malignancy",
                        "criterion": "prior invasive malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "expected disease-free interval of less than 3 years",
                        "criterion": "disease-free interval",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields",
                "criterions": [
                    {
                        "exact_snippets": "Prior radiotherapy to the region of the study cancer",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "region of the study cancer"
                        }
                    },
                    {
                        "exact_snippets": "overlap of radiation fields",
                        "criterion": "overlap of radiation fields",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior radiotherapy to the region of the study cancer",
                                "criterion": "prior radiotherapy",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": "region of the study cancer"
                                }
                            },
                            {
                                "exact_snippets": "overlap of radiation fields",
                                "criterion": "overlap of radiation fields",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.",
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                    {
                        "exact_snippets": "Subjects may not be receiving any other investigational agents",
                        "criterion": "investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Subjects may not be receiving any other investigational agents",
                        "criterion": "investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection",
                        "criterion": "ongoing or active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... symptomatic congestive heart failure",
                        "criterion": "symptomatic congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... unstable angina pectoris",
                        "criterion": "unstable angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would limit compliance with study requirements"
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection",
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                                "requirement": {
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                                }
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                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... symptomatic congestive heart failure",
                                "criterion": "symptomatic congestive heart failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... unstable angina pectoris",
                                "criterion": "unstable angina pectoris",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... cardiac arrhythmia",
                                "criterion": "cardiac arrhythmia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements",
                                "criterion": "psychiatric illness/social situations",
                                "requirement": {
                                    "requirement_type": "impact on compliance",
                                    "expected_value": "would limit compliance with study requirements"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects must not be pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "must not be ... nursing",
                        "criterion": "nursing",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Subjects must not be pregnant",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "must not be ... nursing",
                        "criterion": "nursing",
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                            "requirement_type": "presence",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant",
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                    {
                        "exact_snippets": "History of severe immunosuppression",
                        "criterion": "severe immunosuppression",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "including HIV",
                        "criterion": "HIV",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "organ ... transplant",
                        "criterion": "organ transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "autologous ... stem cell transplant",
                        "criterion": "autologous stem cell transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "allogeneic stem cell transplant",
                        "criterion": "allogeneic stem cell transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of severe immunosuppression",
                                "criterion": "severe immunosuppression",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "including HIV",
                                "criterion": "HIV",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "organ ... transplant",
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                            "requirement_type": "history",
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                        }
                    },
                    {
                        "exact_snippets": "autologous ... stem cell transplant",
                        "criterion": "autologous stem cell transplant",
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                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "allogeneic stem cell transplant",
                        "criterion": "allogeneic stem cell transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "The exclusion criteria will be the same as Phase I except for feeding tube dependence. Patients who are feeding tube dependent are excluded from Phase I to accurately assess treatment associated toxicity affecting swallowing and oral intake. During Phase II, patients who are feeding tube dependent will be eligible to enroll and stratified at randomization.",
                "criterions": [
                    {
                        "exact_snippets": "feeding tube dependence ... Patients who are feeding tube dependent are excluded from Phase I ... During Phase II, patients who are feeding tube dependent will be eligible",
                        "criterion": "feeding tube dependence",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "feeding tube dependence ... Patients who are feeding tube dependent are excluded from Phase I ... During Phase II, patients who are feeding tube dependent will be eligible",
                    "criterion": "feeding tube dependence",
                    "requirement": {
                        "requirement_type": "eligibility",
                        "expected_value": true
                    }
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "Phase I:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Phase II:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "5. Synchronous non-skin cancer primaries outside of the oropharynx, oral cavity, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer. For prostate cancer, patient should not be receiving active treatment. For thyroid cancer, thyroid surgery may occur before or after treatment, provided all other eligibility criteria are met.",
                "criterions": [
                    {
                        "exact_snippets": "Synchronous non-skin cancer primaries outside of the oropharynx, oral cavity, larynx, and hypopharynx",
                        "criterion": "synchronous non-skin cancer primaries",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "outside of the oropharynx",
                                "oral cavity",
                                "larynx",
                                "hypopharynx"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "except for low- and intermediate-risk prostate cancer",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "risk level",
                            "expected_value": [
                                "low",
                                "intermediate"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "For prostate cancer, patient should not be receiving active treatment",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "not receiving active treatment"
                        }
                    },
                    {
                        "exact_snippets": "synchronous well-differentiated thyroid cancer",
                        "criterion": "thyroid cancer",
                        "requirement": {
                            "requirement_type": "differentiation",
                            "expected_value": "well-differentiated"
                        }
                    },
                    {
                        "exact_snippets": "For thyroid cancer, thyroid surgery may occur before or after treatment",
                        "criterion": "thyroid cancer",
                        "requirement": {
                            "requirement_type": "surgery timing",
                            "expected_value": "before or after treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}