{
    "info": {
        "nct_id": "NCT04609280",
        "official_title": "A Single-arm, Single-stage Phase II Trial of Selective Avoidance of Nodal VolumEs at Minimal Risk (SAVER) in the Contralateral Neck of Patients With p16-positive Oropharynx Cancer",
        "inclusion_criteria": "1. Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil or base of tongue)? Note: Cytologic diagnosis from a cervical lymph node (from a paraffin block, not from smears) is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).\n2. Does the patient require elective contralateral radiotherapy in the definitive or adjuvant setting (i.e. base of tongue primary or tonsil with base of tongue invasion, soft palate invasion, or medialized as defined by > 1/3 of the distance from the tonsil to the midline of the soft palate?\n3. Does the patient have clinical stage T1-4, N0, N1 or N3, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET/CT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET/CT)?\n4. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?\n5. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?\n6. Is the patient ≥ 18 years of age?\n7. For women of childbearing potential, was a serum pregnancy test completed within 2 weeks of initiation or radiotherapy?\n8. If yes, was the serum pregnancy test negative?\n9. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.\n10. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?\n2. Does the patient have a carcinoma of the neck of unknown primary origin?\n3. Does the patient have distant metastasis?\n4. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years?\n5. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?\n6. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?\n7. Did the patient have prior surgery of the head and neck excluding superficial removal of cutaneous skin malignancies?\n8. Is the patient homeless?\n9. Does the patient have an active drug or alcohol dependency?\n10. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?\n11. Radiographic evidence of contralateral nodal disease as described below. 1) Max standardized uptake value (SUV) greater than 3.0, or 2) Short-axis diameter is > 1.5 cm for level II nodes, > 0.8 cm for retropharyngeal node, or > 1.0 cm for level III, IV, or V, or 3) Central necrosis or heterogeneous enhancement",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil or base of tongue)? Note: Cytologic diagnosis from a cervical lymph node (from a paraffin block, not from smears) is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).",
            "criterions": [
                {
                    "exact_snippets": "pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma",
                    "criterion": "p16+ squamous cell carcinoma diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma",
                    "criterion": "histological variant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "papillary squamous cell carcinoma",
                                "basaloid squamous cell carcinoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "oropharynx (tonsil or base of tongue)",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "oropharynx",
                                "tonsil",
                                "base of tongue"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Cytologic diagnosis from a cervical lymph node (from a paraffin block, not from smears) is sufficient",
                    "criterion": "cytologic diagnosis from cervical lymph node",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "paraffin block"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical evidence of a primary tumor in the oropharynx",
                    "criterion": "clinical evidence of primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "oropharynx"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation",
                    "criterion": "clinical evidence documentation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "palpation",
                                "imaging",
                                "endoscopic evaluation"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "sufficient to estimate the size of the primary (for T stage)",
                    "criterion": "estimation of primary tumor size",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Does the patient require elective contralateral radiotherapy in the definitive or adjuvant setting (i.e. base of tongue primary or tonsil with base of tongue invasion, soft palate invasion, or medialized as defined by > 1/3 of the distance from the tonsil to the midline of the soft palate?",
            "criterions": [
                {
                    "exact_snippets": "base of tongue primary",
                    "criterion": "base of tongue primary",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tonsil with base of tongue invasion",
                    "criterion": "tonsil with base of tongue invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "soft palate invasion",
                    "criterion": "soft palate invasion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medialized as defined by > 1/3 of the distance from the tonsil to the midline of the soft palate",
                    "criterion": "medialization",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "3 of the distance from the tonsil to the midline of the soft palate"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Does the patient have clinical stage T1-4, N0, N1 or N3, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET/CT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET/CT)?",
            "criterions": [
                {
                    "exact_snippets": "clinical stage T1-4, N0, N1 or N3, and M0 disease (AJCC 8th edition)",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "T2",
                                "T3",
                                "T4"
                            ]
                        },
                        {
                            "requirement_type": "node involvement",
                            "expected_value": [
                                "N0",
                                "N1",
                                "N3"
                            ]
                        },
                        {
                            "requirement_type": "metastasis",
                            "expected_value": "M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "defined by physical examination and appropriate imaging (PET/CT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET/CT)",
                    "criterion": "diagnostic method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "physical examination",
                                "PET/CT",
                                "CT neck with IV contrast",
                                "CT chest without contrast"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?",
            "criterions": [
                {
                    "exact_snippets": "general history and physical examination performed",
                    "criterion": "general history and physical examination",
                    "requirements": [
                        {
                            "requirement_type": "performed_by",
                            "expected_value": [
                                "radiation oncologist",
                                "medical oncologist",
                                "head and neck surgeon"
                            ]
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?",
            "criterions": [
                {
                    "exact_snippets": "Zubrod Performance Status 0-1",
                    "criterion": "Zubrod Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 30 days prior to registration",
                    "criterion": "timeframe for Zubrod Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 30 days prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Is the patient ≥ 18 years of age?",
            "criterions": [
                {
                    "exact_snippets": "patient ≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. For women of childbearing potential, was a serum pregnancy test completed within 2 weeks of initiation or radiotherapy?",
            "criterions": [
                {
                    "exact_snippets": "women of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum pregnancy test completed within 2 weeks of initiation or radiotherapy",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. If yes, was the serum pregnancy test negative?",
            "criterions": [
                {
                    "exact_snippets": "serum pregnancy test negative",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.",
            "criterions": [
                {
                    "exact_snippets": "woman of child-bearing potential",
                    "criterion": "gender and reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive potential",
                            "expected_value": "child-bearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "sexually active male",
                    "criterion": "gender and sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        },
                        {
                            "requirement_type": "sexual activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout participation and at least 180 days following the last study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?",
            "criterions": [
                {
                    "exact_snippets": "patient provide study specific informed consent",
                    "criterion": "study specific informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "consent for mandatory submission of tissue for required p16 review",
                    "criterion": "consent for mandatory submission of tissue for p16 review",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?",
            "criterions": [
                {
                    "exact_snippets": "cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip)",
                    "criterion": "oral cavity cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer considered to be from ... nasopharynx",
                    "criterion": "nasopharynx cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer considered to be from ... hypopharynx",
                    "criterion": "hypopharynx cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer considered to be from ... larynx",
                    "criterion": "larynx cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Does the patient have a carcinoma of the neck of unknown primary origin?",
            "criterions": [
                {
                    "exact_snippets": "carcinoma of the neck of unknown primary origin",
                    "criterion": "carcinoma of the neck",
                    "requirements": [
                        {
                            "requirement_type": "origin",
                            "expected_value": "unknown primary"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Does the patient have distant metastasis?",
            "criterions": [
                {
                    "exact_snippets": "distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years?",
            "criterions": [
                {
                    "exact_snippets": "prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years",
                    "criterion": "prior invasive malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "disease free for a minimum of 3 years",
                    "criterion": "disease-free period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?",
            "criterions": [
                {
                    "exact_snippets": "prior systemic chemotherapy for the study cancer",
                    "criterion": "prior systemic chemotherapy for the study cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?",
            "criterions": [
                {
                    "exact_snippets": "prior radiotherapy to the region of the study cancer",
                    "criterion": "prior radiotherapy to the region of the study cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "overlap of radiation therapy fields",
                    "criterion": "overlap of radiation therapy fields",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Did the patient have prior surgery of the head and neck excluding superficial removal of cutaneous skin malignancies?",
            "criterions": [
                {
                    "exact_snippets": "prior surgery of the head and neck",
                    "criterion": "prior surgery of the head and neck",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding superficial removal of cutaneous skin malignancies",
                    "criterion": "superficial removal of cutaneous skin malignancies",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Is the patient homeless?",
            "criterions": [
                {
                    "exact_snippets": "Is the patient homeless?",
                    "criterion": "homelessness",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Does the patient have an active drug or alcohol dependency?",
            "criterions": [
                {
                    "exact_snippets": "active drug or alcohol dependency",
                    "criterion": "drug dependency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active drug or alcohol dependency",
                    "criterion": "alcohol dependency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?",
            "criterions": [
                {
                    "exact_snippets": "Is the patient pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Is the patient ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing patients that are not receiving chemotherapy",
                    "criterion": "nursing while not receiving chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Radiographic evidence of contralateral nodal disease as described below. 1) Max standardized uptake value (SUV) greater than 3.0, or 2) Short-axis diameter is > 1.5 cm for level II nodes, > 0.8 cm for retropharyngeal node, or > 1.0 cm for level III, IV, or V, or 3) Central necrosis or heterogeneous enhancement",
            "criterions": [
                {
                    "exact_snippets": "Radiographic evidence of contralateral nodal disease",
                    "criterion": "contralateral nodal disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "radiographic"
                        }
                    ]
                },
                {
                    "exact_snippets": "Max standardized uptake value (SUV) greater than 3.0",
                    "criterion": "standardized uptake value (SUV)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Short-axis diameter is > 1.5 cm for level II nodes",
                    "criterion": "short-axis diameter for level II nodes",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Short-axis diameter is ... > 0.8 cm for retropharyngeal node",
                    "criterion": "short-axis diameter for retropharyngeal node",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.8,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Short-axis diameter is ... > 1.0 cm for level III, IV, or V",
                    "criterion": "short-axis diameter for level III, IV, or V nodes",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Central necrosis or heterogeneous enhancement",
                    "criterion": "nodal enhancement",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "central necrosis",
                                "heterogeneous enhancement"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}