{
    "info": {
        "nct_id": "NCT00475657",
        "official_title": "Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer",
        "inclusion_criteria": "* Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).\n* Functional stage from 0 to 2 of the ECOG functional scale\n* No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.\n* Previous bone marrow radiotherapy less than 25% is allowed.\n* There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.\n* Appropriate organic function.\n* Life expectancy estimated at 12 weeks minimum.\n* Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.\n* The patient must be compliant and located close to the trial area for appropriate follow-up.\n* The patient or his/her legal representative must sign an informed consent document.\n* Patients must be at least 18 years of age.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.\n* Having participated in a previous pemetrexed trial.\n* Mixed histologic diagnosis of SCLC and NSCLC.\n* Concurrent illness.\n* Having an active infection.\n* Severe cardiac disease.\n* Having received recently or concurrently a vaccine against yellow fever.\n* Having suffered a previous malignant process other than SCLC.\n* Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.\n* Clinically relevant fluid accumulation in the third space.\n* Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.\n* Concurrent administration of any other anti-tumor treatment.\n* Severe renal failure.\n* Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.\n* Inability or unwillingness to take folic acid and vitamin B12 supplements.\n* Inability to take corticoids.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).",
            "criterions": [
                {
                    "exact_snippets": "Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC)",
                    "criterion": "Small Cell Lung Cancer (SCLC)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": [
                                "histologic",
                                "cytologic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Functional stage from 0 to 2 of the ECOG functional scale",
            "criterions": [
                {
                    "exact_snippets": "Functional stage from 0 to 2 of the ECOG functional scale",
                    "criterion": "ECOG functional scale",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.",
            "criterions": [
                {
                    "exact_snippets": "No previous systemic chemotherapy",
                    "criterion": "previous systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous ... immunotherapy",
                    "criterion": "previous immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous ... biologic therapy",
                    "criterion": "previous biologic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous bone marrow radiotherapy less than 25% is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Previous bone marrow radiotherapy less than 25% is allowed.",
                    "criterion": "bone marrow radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": {
                                "operator": "<",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "complies with the solid tumor response evaluation criteria",
                    "criterion": "compliance with solid tumor response evaluation criteria",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Appropriate organic function.",
            "criterions": [
                {
                    "exact_snippets": "Appropriate organic function.",
                    "criterion": "organic function",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy estimated at 12 weeks minimum.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy estimated at 12 weeks minimum.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.",
            "criterions": [
                {
                    "exact_snippets": "Females must be surgically sterile",
                    "criterion": "female surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Females must be ... postmenopausal",
                    "criterion": "female postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Females must ... follow approved medical contraceptive methods during the treatment period and 6 months afterwards",
                    "criterion": "female contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the treatment period and 6 months afterwards"
                        }
                    ]
                },
                {
                    "exact_snippets": "Males must be surgically sterile",
                    "criterion": "male surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Males must ... use a contraceptive method during the treatment period and during 6 months after treatment",
                    "criterion": "male contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the treatment period and during 6 months after treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must be compliant and located close to the trial area for appropriate follow-up.",
            "criterions": [
                {
                    "exact_snippets": "The patient must be compliant",
                    "criterion": "compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "located close to the trial area",
                    "criterion": "location",
                    "requirements": [
                        {
                            "requirement_type": "proximity",
                            "expected_value": "close to the trial area"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient or his/her legal representative must sign an informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "The patient or his/her legal representative must sign an informed consent document.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be at least 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.",
            "criterions": [
                {
                    "exact_snippets": "received treatment for the last 30 days",
                    "criterion": "treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "drug that has not obtained regulatory approval",
                    "criterion": "drug approval status",
                    "requirements": [
                        {
                            "requirement_type": "approval status",
                            "expected_value": "not obtained"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having participated in a previous pemetrexed trial.",
            "criterions": [
                {
                    "exact_snippets": "Having participated in a previous pemetrexed trial",
                    "criterion": "previous pemetrexed trial participation",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Mixed histologic diagnosis of SCLC and NSCLC.",
            "criterions": [
                {
                    "exact_snippets": "Mixed histologic diagnosis of SCLC and NSCLC.",
                    "criterion": "histologic diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "SCLC",
                                "NSCLC"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent illness.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent illness.",
                    "criterion": "concurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having an active infection.",
            "criterions": [
                {
                    "exact_snippets": "Having an active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe cardiac disease.",
            "criterions": [
                {
                    "exact_snippets": "Severe cardiac disease.",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having received recently or concurrently a vaccine against yellow fever.",
            "criterions": [
                {
                    "exact_snippets": "received recently or concurrently a vaccine against yellow fever",
                    "criterion": "yellow fever vaccine",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "recently or concurrently"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Having suffered a previous malignant process other than SCLC.",
            "criterions": [
                {
                    "exact_snippets": "suffered a previous malignant process other than SCLC",
                    "criterion": "previous malignant process",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": "other than SCLC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.",
            "criterions": [
                {
                    "exact_snippets": "Central nervous system (CNS) metastases require concurrent corticoid therapy.",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "concurrent corticoid therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Treated and stable CNS metastases are allowed.",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically relevant fluid accumulation in the third space.",
            "criterions": [
                {
                    "exact_snippets": "Clinically relevant fluid accumulation in the third space.",
                    "criterion": "fluid accumulation",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "third space"
                        },
                        {
                            "requirement_type": "clinical relevance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.",
            "criterions": [
                {
                    "exact_snippets": "Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.",
                    "criterion": "weight loss",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 weeks prior to trial inclusion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent administration of any other anti-tumor treatment.",
            "criterions": [
                {
                    "exact_snippets": "Concurrent administration of any other anti-tumor treatment.",
                    "criterion": "concurrent anti-tumor treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe renal failure.",
            "criterions": [
                {
                    "exact_snippets": "Severe renal failure",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.",
            "criterions": [
                {
                    "exact_snippets": "Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.",
                    "criterion": "discontinuation of NSAIDS",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability or unwillingness to take folic acid and vitamin B12 supplements.",
            "criterions": [
                {
                    "exact_snippets": "Inability or unwillingness to take folic acid",
                    "criterion": "folic acid supplementation",
                    "requirements": [
                        {
                            "requirement_type": "ability or willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability or unwillingness to take ... vitamin B12 supplements",
                    "criterion": "vitamin B12 supplementation",
                    "requirements": [
                        {
                            "requirement_type": "ability or willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to take corticoids.",
            "criterions": [
                {
                    "exact_snippets": "Inability to take corticoids",
                    "criterion": "corticoid intake ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}