{
    "info": {
        "nct_id": "NCT00270582",
        "official_title": "A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine vs. Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-Small Cell Lung Cancer",
        "inclusion_criteria": "* 1.Written informed consent prior to beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.\n\n  2. Histologically or cytologically proven non-small cell lung carcinoma. 3. Stage IIIB or IV disease, no curative treatment available, candidate for chemotherapy.\n\n  4. Age > 18 years and < 75 years. 5. Performance status WHO performance status 0,1. 6. Previous therapy:\n\n  (a) Chemotherapy: None. (b) Previous radiation therapy : prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal.\n\n  7. Unidimentional or bidimentional measurable disease. 8. Life expectancy > 12 weeks. 9. Laboratory requirements :\n  1. Hematology: Neutrophils * 1.5 109/l, Platelets * 100 109/l, Hemoglobin > 10 g/dl.\n  2. Hepatic function : Total bilirubin < 1.5 UNL, ASAT (SGOT) and ALAT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL ; except in presence of only bone metastasis and in the absence of any liver disorders. Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.\n  3. Renal function : Creatinine < 1 UNL, and creatinine clearance should be > 60 ml/min.\n\n     10.Complete initial lab studies within 2 weeks prior to first infusion, imaging studies within 4 weeks prior to first infusion.\n\n     11.Patients must be accessible for treatment and follow-up.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "* 1.Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation.\n\n  2. Symptomatic central nervous system metastasis, patients with asymptomatic brain metastasis can be accepted if the tumor is irradiated and do not need steroid to control symptom.\n\n  3. Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by NCIC-CTG criteria.\n\n  4. Other serious illness or medical condition :\n  1. congestive heart failure or unstable angina pectoris. High risk uncontrolled arrhythmias.\n  2. history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.\n  3. active uncontrolled infection.\n  4. contraindication for the use of corticosteroids. 5. Past or current history of neoplasm other than non small cell lung cancer, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix within 5 years.\n\n     6. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.\n\n     7. Concurrent treatment with any other anti-cancer therapy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* 1.Written informed consent prior to beginning specific protocol procedures including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent ... must be obtained and documented",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "expected cooperation of the patients for the treatment and follow-up",
                    "criterion": "patient cooperation",
                    "requirements": [
                        {
                            "requirement_type": "expectation",
                            "expected_value": "cooperation for treatment and follow-up"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically or cytologically proven non-small cell lung carcinoma. 3. Stage IIIB or IV disease, no curative treatment available, candidate for chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically proven non-small cell lung carcinoma",
                    "criterion": "non-small cell lung carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage IIIB or IV disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIB",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no curative treatment available",
                    "criterion": "curative treatment availability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "candidate for chemotherapy",
                    "criterion": "chemotherapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Age > 18 years and < 75 years. 5. Performance status WHO performance status 0,1. 6. Previous therapy:",
            "criterions": [
                {
                    "exact_snippets": "Age > 18 years and < 75 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status WHO performance status 0,1.",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "WHO performance status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "(a) Chemotherapy: None. (b) Previous radiation therapy : prior irradiation for NSCLC is permitted, however, the measurable or evaluable non-measurable disease must be completely outside the radiation portal.",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy: None.",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous radiation therapy : prior irradiation for NSCLC is permitted",
                    "criterion": "previous radiation therapy for NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable or evaluable non-measurable disease must be completely outside the radiation portal.",
                    "criterion": "disease location relative to radiation portal",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "completely outside the radiation portal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Unidimentional or bidimentional measurable disease. 8. Life expectancy > 12 weeks. 9. Laboratory requirements :",
            "criterions": [
                {
                    "exact_snippets": "Unidimentional or bidimentional measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "unidimensional",
                                "bidimensional"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy > 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Hematology: Neutrophils * 1.5 109/l, Platelets * 100 109/l, Hemoglobin > 10 g/dl.",
            "criterions": [
                {
                    "exact_snippets": "Neutrophils * 1.5 109/l",
                    "criterion": "neutrophils",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1.5,
                                "unit": "109/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets * 100 109/l",
                    "criterion": "platelets",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 100,
                                "unit": "109/l"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin > 10 g/dl",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Hepatic function : Total bilirubin < 1.5 UNL, ASAT (SGOT) and ALAT (SGPT) < 2.5 UNL, Alkaline phosphatases < 5 UNL ; except in presence of only bone metastasis and in the absence of any liver disorders. Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study.",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin < 1.5 UNL",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ASAT (SGOT) and ALAT (SGPT) < 2.5 UNL",
                    "criterion": "ASAT (SGOT) and ALAT (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatases < 5 UNL",
                    "criterion": "alkaline phosphatases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except in presence of only bone metastasis",
                    "criterion": "bone metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the absence of any liver disorders",
                    "criterion": "liver disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible",
                    "criterion": "ASAT and/or ALAT with alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": [
                                "> 1.5 x UNL",
                                "associated with",
                                "> 2.5 x UNL"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Renal function : Creatinine < 1 UNL, and creatinine clearance should be > 60 ml/min.",
            "criterions": [
                {
                    "exact_snippets": "Creatinine < 1 UNL",
                    "criterion": "creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "UNL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance should be > 60 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10.Complete initial lab studies within 2 weeks prior to first infusion, imaging studies within 4 weeks prior to first infusion.",
            "criterions": [
                {
                    "exact_snippets": "Complete initial lab studies within 2 weeks prior to first infusion",
                    "criterion": "initial lab studies",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": "within 2 weeks prior to first infusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "imaging studies within 4 weeks prior to first infusion",
                    "criterion": "imaging studies",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": "within 4 weeks prior to first infusion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11.Patients must be accessible for treatment and follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be accessible for treatment",
                    "criterion": "patient accessibility for treatment",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must be accessible for ... follow-up",
                    "criterion": "patient accessibility for follow-up",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* 1.Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating patients",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients of childbearing potential must implement adequate contraceptive measures",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "implementation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Symptomatic central nervous system metastasis, patients with asymptomatic brain metastasis can be accepted if the tumor is irradiated and do not need steroid to control symptom.",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic brain metastasis ... tumor is irradiated",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "irradiated"
                        }
                    ]
                },
                {
                    "exact_snippets": "do not need steroid to control symptom",
                    "criterion": "steroid use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Pre-existing motor or sensory neurotoxicity of a severity > grade 1 by NCIC-CTG criteria.",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing motor or sensory neurotoxicity ... > grade 1 by NCIC-CTG criteria",
                    "criterion": "motor or sensory neurotoxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "grade by NCIC-CTG criteria"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Other serious illness or medical condition :",
            "criterions": [
                {
                    "exact_snippets": "Other serious illness or medical condition",
                    "criterion": "serious illness or medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. congestive heart failure or unstable angina pectoris. High risk uncontrolled arrhythmias.",
            "criterions": [
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "High risk uncontrolled arrhythmias",
                    "criterion": "uncontrolled arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.",
            "criterions": [
                {
                    "exact_snippets": "history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures",
                    "criterion": "neurological or psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "that would prohibit the understanding and giving of informed consent",
                    "criterion": "ability to understand and give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. active uncontrolled infection.",
            "criterions": [
                {
                    "exact_snippets": "active uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. contraindication for the use of corticosteroids. 5. Past or current history of neoplasm other than non small cell lung cancer, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix within 5 years.",
            "criterions": [
                {
                    "exact_snippets": "contraindication for the use of corticosteroids",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Past or current history of neoplasm other than non small cell lung cancer",
                    "criterion": "neoplasm history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except for curatively treated non melanoma skin cancer",
                    "criterion": "non melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "curatively treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "in situ carcinoma of the cervix within 5 years",
                    "criterion": "in situ carcinoma of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with other experimental drugs.",
                    "criterion": "concurrent treatment with experimental drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Participation in another clinical trial with any investigational drug within 30 days prior to study entry.",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Concurrent treatment with any other anti-cancer therapy.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent treatment with any other anti-cancer therapy.",
                    "criterion": "concurrent anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}