{
    "info": {
        "nct_id": "NCT00301782",
        "official_title": "Randomized Phase II Trial of Intensive Induction Chemotherapy (CBOP/BEP) and Standard BEP Chemotherapy in Poor Prognosis Male Germ Cell Tumors",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 16 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Nonseminoma germ cell tumor of any extracranial primary site diagnosed by 1 of the following methods:\n\n  * Histologic confirmation\n  * Alpha-fetoprotein (AFP) > 1,000 ng/mL or human chorionic gonadotropin (hCG) > 5,000 IU/L with appropriate clinical picture in a man < 45 years of age\n* Poor prognosis features as defined by ≥ 1 of the following:\n\n  * AFP > 10,000 ng/mL\n  * hCG > 50,000 IU/L\n  * Lactic dehydrogenase > 10 times normal\n  * Nonpulmonary visceral metastases\n  * Mediastinal primary site\n\nPATIENT CHARACTERISTICS:\n\n* Male\n* WHO performance status 0-3\n* Glomerular filtration rate > 50 mL/min\n\n  * Less than 50 mL/min eligible if due to obstructive neuropathy that can be relieved by stenting or nephrostomy\n* No comorbid condition that would prevent treatment\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy except low-dose chemotherapy to stabilize disease before study therapy"
    },
    "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 be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 16 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 16 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Nonseminoma germ cell tumor of any extracranial primary site diagnosed by 1 of the following methods:",
            "criterions": [
                {
                    "exact_snippets": "Nonseminoma germ cell tumor of any extracranial primary site",
                    "criterion": "nonseminoma germ cell tumor",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "extracranial primary site"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologic confirmation",
            "criterions": [
                {
                    "exact_snippets": "Histologic confirmation",
                    "criterion": "histologic confirmation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alpha-fetoprotein (AFP) > 1,000 ng/mL or human chorionic gonadotropin (hCG) > 5,000 IU/L with appropriate clinical picture in a man < 45 years of age",
            "criterions": [
                {
                    "exact_snippets": "Alpha-fetoprotein (AFP) > 1,000 ng/mL",
                    "criterion": "Alpha-fetoprotein (AFP) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "human chorionic gonadotropin (hCG) > 5,000 IU/L",
                    "criterion": "human chorionic gonadotropin (hCG) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5000,
                                "unit": "IU/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "appropriate clinical picture",
                    "criterion": "clinical picture",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "man < 45 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 45,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "man",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Poor prognosis features as defined by ≥ 1 of the following:",
            "criterions": [
                {
                    "exact_snippets": "Poor prognosis features",
                    "criterion": "prognosis features",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "poor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AFP > 10,000 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "AFP > 10,000 ng/mL",
                    "criterion": "AFP",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 10000,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* hCG > 50,000 IU/L",
            "criterions": [
                {
                    "exact_snippets": "hCG > 50,000 IU/L",
                    "criterion": "hCG level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50000,
                                "unit": "IU/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lactic dehydrogenase > 10 times normal",
            "criterions": [
                {
                    "exact_snippets": "Lactic dehydrogenase > 10 times normal",
                    "criterion": "lactic dehydrogenase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "times normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nonpulmonary visceral metastases",
            "criterions": [
                {
                    "exact_snippets": "Nonpulmonary visceral metastases",
                    "criterion": "visceral metastases",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "nonpulmonary"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mediastinal primary site",
            "criterions": [
                {
                    "exact_snippets": "Mediastinal primary site",
                    "criterion": "primary site",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "mediastinal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male",
            "criterions": [
                {
                    "exact_snippets": "Male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO performance status 0-3",
            "criterions": [
                {
                    "exact_snippets": "WHO performance status 0-3",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Glomerular filtration rate > 50 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Glomerular filtration rate > 50 mL/min",
                    "criterion": "glomerular filtration rate",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Less than 50 mL/min eligible if due to obstructive neuropathy that can be relieved by stenting or nephrostomy",
            "criterions": [
                {
                    "exact_snippets": "Less than 50 mL/min",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "glomerular filtration rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "obstructive neuropathy that can be relieved by stenting or nephrostomy",
                    "criterion": "obstructive neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "relievability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment options",
                            "expected_value": [
                                "stenting",
                                "nephrostomy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No comorbid condition that would prevent treatment",
            "criterions": [
                {
                    "exact_snippets": "No comorbid condition that would prevent treatment",
                    "criterion": "comorbid condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy except low-dose chemotherapy to stabilize disease before study therapy",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except low-dose chemotherapy to stabilize disease before study therapy",
                    "criterion": "low-dose chemotherapy to stabilize disease before study therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}