{
    "info": {
        "nct_id": "NCT00864331",
        "official_title": "Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy",
        "inclusion_criteria": "* Histologically or cytologically confirmed NSCLC\n* Stage IIIA/IIIB staged with\n* CT chest and upper abdomen\n* Liver, renal, hematological reserve appropriate (according to \"standard\" institutional values)\n* Brain CT and/or bone scan only if clinical symptoms request such investigation\n* Performance status KPS 60-90\n* No second cancer except skin non-melanoma\n* No previous treatment\n* Patient must be contactable for follow-up\n* Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)\n* Life expectancy > 3 months\n* Patient must be able and willing to give informed consent, and fill in questionnaires\n\nStudy A\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Stage III B \"wet\" (existing pleural effusion , but not necessarily cytologically verified)\n* RT field > 200 cm2\n* Pregnancy\n\nStudy B Inclusion Criteria:\n\n* KPS 60-90\n* Stage IV and Stage III B (existing pleural effusions , but not necessarily cytologically verified)\n* Histologically or cytologically confirmed\n* CT staged disease (thorax and possible upper abdomen)\n* No second cancer except skin non-melanoma\n* Liver, renal, haematological reserve appropriate (according to \"standard\" institutional values)\n* No previous treatment\n* Patient must be contactable for follow-up\n* Patient must be able and willing to give informed consent and fill in questionnaires\n* Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)\n* Life expectancy > 3 months\n\nStudy B Exclusion Criteria:\n\n* Brain metastasis (brain CT and/or MRI not needed, unless symptoms exist - clinically indicated)\n* RT field > 200 cm2\n* Pregnancy\n* A-P separation too large to be adequately treated with 60-Co (?)",
        "miscellaneous_criteria": "Study A"
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed NSCLC",
                    "criterion": "NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IIIA/IIIB staged with",
            "criterions": [
                {
                    "exact_snippets": "Stage IIIA/IIIB",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIA",
                                "IIIB"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CT chest and upper abdomen",
            "criterions": [
                {
                    "exact_snippets": "CT chest",
                    "criterion": "CT scan of chest",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CT ... upper abdomen",
                    "criterion": "CT scan of upper abdomen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Liver, renal, hematological reserve appropriate (according to \"standard\" institutional values)",
            "criterions": [
                {
                    "exact_snippets": "Liver ... appropriate (according to \"standard\" institutional values)",
                    "criterion": "liver reserve",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "standard institutional values"
                        }
                    ]
                },
                {
                    "exact_snippets": "renal ... appropriate (according to \"standard\" institutional values)",
                    "criterion": "renal reserve",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "standard institutional values"
                        }
                    ]
                },
                {
                    "exact_snippets": "hematological reserve appropriate (according to \"standard\" institutional values)",
                    "criterion": "hematological reserve",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "standard institutional values"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brain CT and/or bone scan only if clinical symptoms request such investigation",
            "criterions": [
                {
                    "exact_snippets": "Brain CT and/or bone scan only if clinical symptoms request such investigation",
                    "criterion": "brain CT and/or bone scan",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": "only if clinical symptoms request such investigation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Performance status KPS 60-90",
            "criterions": [
                {
                    "exact_snippets": "Performance status KPS 60-90",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 90,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No second cancer except skin non-melanoma",
            "criterions": [
                {
                    "exact_snippets": "No second cancer except skin non-melanoma",
                    "criterion": "second cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except skin non-melanoma",
                    "criterion": "skin non-melanoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous treatment",
            "criterions": [
                {
                    "exact_snippets": "No previous treatment",
                    "criterion": "previous treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be contactable for follow-up",
            "criterions": [
                {
                    "exact_snippets": "Patient must be contactable for follow-up",
                    "criterion": "patient contactability",
                    "requirements": [
                        {
                            "requirement_type": "contactability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)",
            "criterions": [
                {
                    "exact_snippets": "able to start treatment within 2 weeks from randomization",
                    "criterion": "treatment start time",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy > 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be able and willing to give informed consent, and fill in questionnaires",
            "criterions": [
                {
                    "exact_snippets": "Patient must be able and willing to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fill in questionnaires",
                    "criterion": "questionnaire completion",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Stage III B \"wet\" (existing pleural effusion , but not necessarily cytologically verified)",
            "criterions": [
                {
                    "exact_snippets": "Stage III B",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "III B"
                        }
                    ]
                },
                {
                    "exact_snippets": "existing pleural effusion",
                    "criterion": "pleural effusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* RT field > 200 cm2",
            "criterions": [
                {
                    "exact_snippets": "RT field > 200 cm2",
                    "criterion": "RT field",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 200,
                                "unit": "cm2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* KPS 60-90",
            "criterions": [
                {
                    "exact_snippets": "KPS 60-90",
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 60,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 90,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IV and Stage III B (existing pleural effusions , but not necessarily cytologically verified)",
            "criterions": [
                {
                    "exact_snippets": "Stage IV",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage III B",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "III B"
                        }
                    ]
                },
                {
                    "exact_snippets": "existing pleural effusions",
                    "criterion": "pleural effusions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* CT staged disease (thorax and possible upper abdomen)",
            "criterions": [
                {
                    "exact_snippets": "CT staged disease",
                    "criterion": "disease staging",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "CT"
                        }
                    ]
                },
                {
                    "exact_snippets": "thorax",
                    "criterion": "thorax",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "possible upper abdomen",
                    "criterion": "upper abdomen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "possible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No second cancer except skin non-melanoma",
            "criterions": [
                {
                    "exact_snippets": "No second cancer except skin non-melanoma",
                    "criterion": "second cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No second cancer except skin non-melanoma",
                    "criterion": "skin non-melanoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Liver, renal, haematological reserve appropriate (according to \"standard\" institutional values)",
            "criterions": [
                {
                    "exact_snippets": "Liver ... reserve appropriate (according to \"standard\" institutional values)",
                    "criterion": "liver reserve",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "standard institutional values"
                        }
                    ]
                },
                {
                    "exact_snippets": "renal ... reserve appropriate (according to \"standard\" institutional values)",
                    "criterion": "renal reserve",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "standard institutional values"
                        }
                    ]
                },
                {
                    "exact_snippets": "haematological reserve appropriate (according to \"standard\" institutional values)",
                    "criterion": "haematological reserve",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "standard institutional values"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous treatment",
            "criterions": [
                {
                    "exact_snippets": "No previous treatment",
                    "criterion": "previous treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be contactable for follow-up",
            "criterions": [
                {
                    "exact_snippets": "Patient must be contactable for follow-up",
                    "criterion": "patient contactability",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must be able and willing to give informed consent and fill in questionnaires",
            "criterions": [
                {
                    "exact_snippets": "Patient must be able and willing to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fill in questionnaires",
                    "criterion": "questionnaire completion",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)",
            "criterions": [
                {
                    "exact_snippets": "able to start treatment within 2 weeks from randomization",
                    "criterion": "treatment start time",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy > 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brain metastasis (brain CT and/or MRI not needed, unless symptoms exist - clinically indicated)",
            "criterions": [
                {
                    "exact_snippets": "Brain metastasis",
                    "criterion": "brain metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* RT field > 200 cm2",
            "criterions": [
                {
                    "exact_snippets": "RT field > 200 cm2",
                    "criterion": "RT field",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 200,
                                "unit": "cm2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A-P separation too large to be adequately treated with 60-Co (?)",
            "criterions": [
                {
                    "exact_snippets": "A-P separation too large",
                    "criterion": "A-P separation",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": "too large"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated with 60-Co",
                    "criterion": "treatment with 60-Co",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Study A",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "Study B Inclusion Criteria:",
            "criterions": []
        },
        {
            "line": "Study B Exclusion Criteria:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": [
        {
            "line": "Study A",
            "criterions": []
        }
    ]
}