{
    "info": {
        "nct_id": "NCT00346320",
        "official_title": "A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)\n\n  * Stage I or II peripheral disease\n\n    * T1, N0, M0\n    * T2 (≤ 5 cm), N0, M0\n    * T3 (≤ 5 cm, chest wall primary tumor only), N0, M0\n    * No T2-T3 primary tumors > 5 cm or any T1-T3 tumor of the mainstem bronchus involvement\n    * No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose)\n    * Hilar or mediastinal lymph nodes ≤ 1 cm considered N0\n  * Any of the following primary cancer types:\n\n    * Squamous cell carcinoma\n    * Adenocarcinoma\n    * Large cell carcinoma\n    * Bronchioloalveolar cell carcinoma\n    * Non-small cell carcinoma not otherwise specified\n* Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable)\n* Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed\n\n  * If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen\n* Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs\n* No ataxia telangiectasia\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Not pregnant or nursing\n* Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply)\n* No active systemic, pulmonary, or pericardial infection\n* No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix.\n\n  * Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer)\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior radiotherapy to the area of the primary tumor\n* No prior or concurrent chemotherapy or immunotherapy for this tumor"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS:",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)",
                    "criterion": "non-small cell lung cancer (NSCLC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage I or II peripheral disease",
            "criterions": [
                {
                    "exact_snippets": "Stage I or II peripheral disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage I",
                                "Stage II"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage I or II peripheral disease",
                    "criterion": "disease location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "peripheral"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T1, N0, M0",
            "criterions": [
                {
                    "exact_snippets": "T1",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T1"
                        }
                    ]
                },
                {
                    "exact_snippets": "N0",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T2 (≤ 5 cm), N0, M0",
            "criterions": [
                {
                    "exact_snippets": "T2 (≤ 5 cm)",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T2"
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "M0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T3 (≤ 5 cm, chest wall primary tumor only), N0, M0",
            "criterions": [
                {
                    "exact_snippets": "T3 (≤ 5 cm, chest wall primary tumor only)",
                    "criterion": "T3 primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "chest wall"
                        },
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0",
                    "criterion": "regional lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No T2-T3 primary tumors > 5 cm or any T1-T3 tumor of the mainstem bronchus involvement",
            "criterions": [
                {
                    "exact_snippets": "No T2-T3 primary tumors > 5 cm",
                    "criterion": "T2-T3 primary tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any T1-T3 tumor of the mainstem bronchus involvement",
                    "criterion": "T1-T3 tumor mainstem bronchus involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose)",
            "criterions": [
                {
                    "exact_snippets": "No T1-T3 tumor in the lung apex",
                    "criterion": "T1-T3 tumor in the lung apex",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose",
                    "criterion": "tumor position affecting brachial plexus irradiation",
                    "requirements": [
                        {
                            "requirement_type": "position",
                            "expected_value": "not resulting in irradiation of the brachial plexus to the prescribed dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hilar or mediastinal lymph nodes ≤ 1 cm considered N0",
            "criterions": [
                {
                    "exact_snippets": "Hilar or mediastinal lymph nodes ≤ 1 cm",
                    "criterion": "hilar or mediastinal lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any of the following primary cancer types:",
            "criterions": [
                {
                    "exact_snippets": "Any of the following primary cancer types:",
                    "criterion": "primary cancer type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Squamous cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Squamous cell carcinoma",
                    "criterion": "squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Large cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Large cell carcinoma",
                    "criterion": "large cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bronchioloalveolar cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Bronchioloalveolar cell carcinoma",
                    "criterion": "Bronchioloalveolar cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Non-small cell carcinoma not otherwise specified",
            "criterions": [
                {
                    "exact_snippets": "Non-small cell carcinoma not otherwise specified",
                    "criterion": "non-small cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "specificity",
                            "expected_value": "not otherwise specified"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable)",
            "criterions": [
                {
                    "exact_snippets": "Underlying physiological medical condition that prohibits surgery",
                    "criterion": "underlying physiological medical condition",
                    "requirements": [
                        {
                            "requirement_type": "prohibition of surgery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "low probability of tolerating general anesthesia",
                    "criterion": "tolerance to general anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "probability",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.5,
                                "unit": "probability"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "low probability of tolerating ... the operation",
                    "criterion": "tolerance to the operation",
                    "requirements": [
                        {
                            "requirement_type": "probability",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.5,
                                "unit": "probability"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "low probability of tolerating ... the postoperative recovery period",
                    "criterion": "tolerance to the postoperative recovery period",
                    "requirements": [
                        {
                            "requirement_type": "probability",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.5,
                                "unit": "probability"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "low probability of tolerating ... the removal of adjacent functional lung",
                    "criterion": "tolerance to removal of adjacent functional lung",
                    "requirements": [
                        {
                            "requirement_type": "probability",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.5,
                                "unit": "probability"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed",
            "criterions": [
                {
                    "exact_snippets": "Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed",
                    "criterion": "cytologic specimens",
                    "requirements": [
                        {
                            "requirement_type": "method of obtaining",
                            "expected_value": [
                                "brushing",
                                "washing",
                                "needle aspiration"
                            ]
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "defined lesion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen",
            "criterions": [
                {
                    "exact_snippets": "sputum cytology alone is used for diagnosis",
                    "criterion": "sputum cytology",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": "alone for diagnosis"
                        }
                    ]
                },
                {
                    "exact_snippets": "it must be confirmed on a second specimen",
                    "criterion": "confirmation on a second specimen",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs",
            "criterions": [
                {
                    "exact_snippets": "Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs",
                    "criterion": "radiotherapy plan",
                    "requirements": [
                        {
                            "requirement_type": "dose-volume constraints",
                            "expected_value": "meets for critical organs"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No ataxia telangiectasia",
            "criterions": [
                {
                    "exact_snippets": "No ataxia telangiectasia",
                    "criterion": "ataxia telangiectasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply)",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to complete a quality of life questionnaire",
                    "criterion": "ability and willingness to complete a quality of life questionnaire",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless not literate in either English or French",
                    "criterion": "literacy in English or French",
                    "requirements": [
                        {
                            "requirement_type": "literacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active systemic, pulmonary, or pericardial infection",
            "criterions": [
                {
                    "exact_snippets": "No active systemic ... infection",
                    "criterion": "systemic infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No active ... pulmonary ... infection",
                    "criterion": "pulmonary infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No active ... pericardial infection",
                    "criterion": "pericardial infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix.",
            "criterions": [
                {
                    "exact_snippets": "No previous malignancy",
                    "criterion": "previous malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated nonmelanomatous skin cancer",
                    "criterion": "nonmelanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer)",
            "criterions": [
                {
                    "exact_snippets": "Previous diagnosis of cancer",
                    "criterion": "previous cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "free of recurrence and metastases for ≥ 2 years",
                    "criterion": "cancer recurrence and metastases",
                    "requirements": [
                        {
                            "requirement_type": "recurrence and metastases status",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 0,
                                        "unit": "recurrence"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 0,
                                        "unit": "metastases"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last recurrence or metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "in the opinion of the treating physician, does not have a substantial risk of recurrence",
                    "criterion": "risk of cancer recurrence",
                    "requirements": [
                        {
                            "requirement_type": "risk assessment",
                            "expected_value": "not substantial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior radiotherapy to the area of the primary tumor",
            "criterions": [
                {
                    "exact_snippets": "No prior radiotherapy to the area of the primary tumor",
                    "criterion": "prior radiotherapy to the area of the primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior or concurrent chemotherapy or immunotherapy for this tumor",
            "criterions": [
                {
                    "exact_snippets": "No prior or concurrent chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior or concurrent",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior or concurrent ... immunotherapy for this tumor",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior or concurrent",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ]
}