{
    "info": {
        "nct_id": "NCT05388773",
        "official_title": "Phase II Trial of Transoral Surgical Resection Followed by De-escalated Adjuvant IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer",
        "inclusion_criteria": "* ECOG performance status of 0 or 1 or Karnofsky score 80-100.\n* Newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx and resectable oropharyngeal disease.\n* Patients must be deemed eligible for a TOS procedure with no evidence of distant metastasis as determined by imaging studies.\n* Biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node.\n* Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory.\n* No prior radiation above the clavicles.\n* Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancer.\n* Patients with congestive heart failure > NYHA Class II, CVA/TIA, unstable angina, or myocardial infarction within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist.\n* Acceptable renal and hepatic function within 4 weeks prior to registration as predefined.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* No evidence of extensive or \"matted/fixed\" pathologic adenopathy on preoperative imaging.\n* Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy.\n* No intercurrent illness likely to interfere with protocol therapy or prevent surgical resection.\n* No uncontrolled diabetes, infection despite antibiotics, or hypertension within 30 days prior to registration.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* ECOG performance status of 0 or 1 or Karnofsky score 80-100.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky score 80-100",
                    "criterion": "Karnofsky score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 80,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Newly diagnosed, histologically or cytologically confirmed SCC or undifferentiated carcinoma of the oropharynx and resectable oropharyngeal disease.",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed",
                    "criterion": "diagnosis status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "SCC or undifferentiated carcinoma of the oropharynx",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "SCC",
                                "undifferentiated carcinoma"
                            ]
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "oropharynx"
                        }
                    ]
                },
                {
                    "exact_snippets": "resectable oropharyngeal disease",
                    "criterion": "disease resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be deemed eligible for a TOS procedure with no evidence of distant metastasis as determined by imaging studies.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be deemed eligible for a TOS procedure",
                    "criterion": "TOS procedure eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no evidence of distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "as determined by imaging studies",
                    "criterion": "imaging studies",
                    "requirements": [
                        {
                            "requirement_type": "method of determination",
                            "expected_value": "imaging studies"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node.",
            "criterions": [
                {
                    "exact_snippets": "Biopsy-proven p16+ oropharynx cancer",
                    "criterion": "p16+ oropharynx cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy-proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic evidence of invasive squamous cell carcinoma",
                    "criterion": "invasive squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologic evidence"
                        }
                    ]
                },
                {
                    "exact_snippets": "obtained from the primary tumor or metastatic lymph node",
                    "criterion": "source of histologic evidence",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "primary tumor",
                                "metastatic lymph node"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory.",
            "criterions": [
                {
                    "exact_snippets": "Carcinoma of the oropharynx",
                    "criterion": "carcinoma of the oropharynx",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "associated with HPV",
                    "criterion": "HPV association",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "p16 protein expression",
                    "criterion": "p16 protein expression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "using immunohistochemistry (IHC)",
                    "criterion": "immunohistochemistry (IHC)",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "immunohistochemistry (IHC)"
                        }
                    ]
                },
                {
                    "exact_snippets": "performed by a CLIA approved laboratory",
                    "criterion": "CLIA approved laboratory",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": "CLIA"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiation above the clavicles.",
            "criterions": [
                {
                    "exact_snippets": "No prior radiation above the clavicles.",
                    "criterion": "prior radiation",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "above the clavicles"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancer.",
            "criterions": [
                {
                    "exact_snippets": "history of a curatively treated malignancy ... must be disease-free for at least two years",
                    "criterion": "curatively treated malignancy",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for carcinoma in situ of cervix",
                    "criterion": "carcinoma in situ of cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... melanoma in-situ (if fully resected)",
                    "criterion": "melanoma in-situ",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "resection status",
                            "expected_value": "fully resected"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... non-melanomatous skin cancer",
                    "criterion": "non-melanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with congestive heart failure > NYHA Class II, CVA/TIA, unstable angina, or myocardial infarction within the last 6 months prior to registration must be evaluated by a cardiologist and/or neurologist.",
            "criterions": [
                {
                    "exact_snippets": "congestive heart failure > NYHA Class II",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NYHA Class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "CVA/TIA",
                    "criterion": "CVA/TIA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the last 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acceptable renal and hepatic function within 4 weeks prior to registration as predefined.",
            "criterions": [
                {
                    "exact_snippets": "Acceptable renal ... function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "predefined"
                        }
                    ]
                },
                {
                    "exact_snippets": "Acceptable ... hepatic function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "predefined"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* No evidence of extensive or \"matted/fixed\" pathologic adenopathy on preoperative imaging.",
            "criterions": [
                {
                    "exact_snippets": "No evidence of extensive or \"matted/fixed\" pathologic adenopathy on preoperative imaging.",
                    "criterion": "extensive pathologic adenopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No evidence of extensive or \"matted/fixed\" pathologic adenopathy on preoperative imaging.",
                    "criterion": "matted/fixed pathologic adenopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women must not be pregnant or breast-feeding due to the teratogenicity of chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Women must not be pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No intercurrent illness likely to interfere with protocol therapy or prevent surgical resection.",
            "criterions": [
                {
                    "exact_snippets": "No intercurrent illness likely to interfere with protocol therapy",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "interference with protocol therapy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No intercurrent illness likely to ... prevent surgical resection",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "prevention of surgical resection",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled diabetes, infection despite antibiotics, or hypertension within 30 days prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "infection despite antibiotics",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "response to antibiotics",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypertension within 30 days prior to registration",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}