{
    "info": {
        "nct_id": "NCT00002476",
        "official_title": "Phase III Randomized Study of Radiotherapy Alone vs With Concurrent Chemotherapy With MTX or VBMF (VCR/BLEO/MTX/5-FU) vs Subsequent Chemotherapy vs Concurrent and Subsequent Chemotherapy in Patients With Advanced Head and Neck Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed squamous cell cancer of the head and neck suitable for treatment with radiotherapy T2, T3, or T4 primary lesions Any N No distant metastasis May also be anaplastic carcinoma, verrucous carcinoma, or transitional cell carcinoma (as of 1/97) No occult primaries (as of 1/97) No adenocarcinomas, lymphomas, or melanomas (as of 1/97) Synchronous head and neck tumors are eligible (tumor with the worse prognosis is entered into study) (as of 1/97) Patients receiving surgery to neck nodes only must be randomized as surgery patients (as of 1/97) Patients with tumors of the oral cavity or oropharynx may additionally elect randomization to nodal irradiation vs. no further therapy provided there is no second primary\n\nPATIENT CHARACTERISTICS: Age: 75 and under for patients electing participation in the nodal vs. no nodal irradiation portion of the study Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fit for any protocol treatment option Willing to receive any protocol treatment option Prior malignancy allowed provided the treating clinician considers the patient cured\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior therapy Endocrine therapy: No prior therapy Radiotherapy: No prior therapy Surgery: Prior biopsy or excision allowed"
    },
    "inclusion_lines": [
        {
            "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": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Histologically confirmed squamous cell cancer of the head and neck suitable for treatment with radiotherapy T2, T3, or T4 primary lesions Any N No distant metastasis May also be anaplastic carcinoma, verrucous carcinoma, or transitional cell carcinoma (as of 1/97) No occult primaries (as of 1/97) No adenocarcinomas, lymphomas, or melanomas (as of 1/97) Synchronous head and neck tumors are eligible (tumor with the worse prognosis is entered into study) (as of 1/97) Patients receiving surgery to neck nodes only must be randomized as surgery patients (as of 1/97) Patients with tumors of the oral cavity or oropharynx may additionally elect randomization to nodal irradiation vs. no further therapy provided there is no second primary",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed squamous cell cancer of the head and neck",
                    "criterion": "squamous cell cancer of the head and neck",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "suitable for treatment with radiotherapy",
                    "criterion": "suitability for treatment with radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "T2, T3, or T4 primary lesions",
                    "criterion": "primary lesion stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T2",
                                "T3",
                                "T4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Any N",
                    "criterion": "nodal involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "Any N"
                        }
                    ]
                },
                {
                    "exact_snippets": "No distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "May also be anaplastic carcinoma, verrucous carcinoma, or transitional cell carcinoma",
                    "criterion": "carcinoma type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "anaplastic carcinoma",
                                "verrucous carcinoma",
                                "transitional cell carcinoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "No occult primaries",
                    "criterion": "occult primaries",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No adenocarcinomas, lymphomas, or melanomas",
                    "criterion": "cancer type exclusion",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "adenocarcinomas",
                                "lymphomas",
                                "melanomas"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Synchronous head and neck tumors are eligible",
                    "criterion": "synchronous head and neck tumors",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving surgery to neck nodes only must be randomized as surgery patients",
                    "criterion": "surgery to neck nodes",
                    "requirements": [
                        {
                            "requirement_type": "randomization",
                            "expected_value": "surgery patients"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with tumors of the oral cavity or oropharynx may additionally elect randomization to nodal irradiation vs. no further therapy provided there is no second primary",
                    "criterion": "tumors of the oral cavity or oropharynx",
                    "requirements": [
                        {
                            "requirement_type": "randomization option",
                            "expected_value": "nodal irradiation vs. no further therapy"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "no second primary"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: 75 and under for patients electing participation in the nodal vs. no nodal irradiation portion of the study Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fit for any protocol treatment option Willing to receive any protocol treatment option Prior malignancy allowed provided the treating clinician considers the patient cured",
            "criterions": [
                {
                    "exact_snippets": "Age: 75 and under",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum age",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Fit for any protocol treatment option",
                    "criterion": "fitness for protocol treatment",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Willing to receive any protocol treatment option",
                    "criterion": "willingness to receive protocol treatment",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior malignancy allowed provided the treating clinician considers the patient cured",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "cured status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior therapy Endocrine therapy: No prior therapy Radiotherapy: No prior therapy Surgery: Prior biopsy or excision allowed",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy: No prior therapy",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Chemotherapy: No prior therapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Endocrine therapy: No prior therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Radiotherapy: No prior therapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Surgery: Prior biopsy or excision allowed",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "prior biopsy or excision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}