{
    "info": {
        "nct_id": "NCT00003182",
        "official_title": "A Phase I/II Study Using Cisplatin and Gemcitabine (Gemzar) for Advanced Head and Neck Cancer (Squamous Cell Carcinoma)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically proven stage III or IV squamous cell carcinoma of the head and neck that is surgically unresectable and not curable by radiation therapy Upper aerodigestive tract only Unresectable or recurrent disease following initial therapy with surgery and/or radiation Measurable or evaluable disease\n\nPATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times institutional normal Transaminases no greater than 3 times institutional normal Renal: Creatinine clearance greater than 40 mL/min Cardiovascular: Adequate cardiac function No heart failure Pulmonary: Adequate pulmonary function not requiring supplemental oxygen Other: Not pregnant Fertile patients must use adequate contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy allowed Surgery: Prior surgery 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 proven stage III or IV squamous cell carcinoma of the head and neck that is surgically unresectable and not curable by radiation therapy Upper aerodigestive tract only Unresectable or recurrent disease following initial therapy with surgery and/or radiation Measurable or evaluable disease",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven stage III or IV squamous cell carcinoma of the head and neck",
                    "criterion": "squamous cell carcinoma of the head and neck",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        },
                        {
                            "requirement_type": "histological confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surgically unresectable",
                    "criterion": "surgical resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not curable by radiation therapy",
                    "criterion": "curability by radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "curability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Upper aerodigestive tract only",
                    "criterion": "location of disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "Upper aerodigestive tract"
                        }
                    ]
                },
                {
                    "exact_snippets": "Unresectable or recurrent disease following initial therapy with surgery and/or radiation",
                    "criterion": "disease status after initial therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "unresectable",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Measurable or evaluable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": [
                                "measurable",
                                "evaluable"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy allowed Surgery: Prior surgery allowed",
            "criterions": [
                {
                    "exact_snippets": "Biologic therapy: Not specified",
                    "criterion": "biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Chemotherapy: Not specified",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Endocrine therapy: Not specified",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Radiotherapy: Prior radiation therapy allowed",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Surgery: Prior surgery allowed",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times institutional normal Transaminases no greater than 3 times institutional normal Renal: Creatinine clearance greater than 40 mL/min Cardiovascular: Adequate cardiac function No heart failure Pulmonary: Adequate pulmonary function not requiring supplemental oxygen Other: Not pregnant Fertile patients must use adequate contraception",
            "criterions": [
                {
                    "exact_snippets": "Age: Over 18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: SWOG 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "SWOG 0-2"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Bilirubin no greater than 3 times institutional normal",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "maximum level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times institutional normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: ... Transaminases no greater than 3 times institutional normal",
                    "criterion": "transaminases level",
                    "requirements": [
                        {
                            "requirement_type": "maximum level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times institutional normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine clearance greater than 40 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "minimum clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular: Adequate cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular: ... No heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pulmonary: Adequate pulmonary function not requiring supplemental oxygen",
                    "criterion": "pulmonary function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "supplemental oxygen requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "pregnancy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: Fertile patients must use adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "requirement for fertile patients",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ]
}