{
    "info": {
        "nct_id": "NCT01076231",
        "official_title": "Feasibility and PhaseI/II Trial of Preoperative Proton Beam Radiotherapy With Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus NSCLC",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion\n\n* Histologically confirmed diagnosis of NSCLC\n* Stage IIIA or Potentially resectable superior sulcus tumors\n* No evidence of distant metastatic disease as documented by MRI of the brain and PET/CT\n* Patients must have a Karnofsky Performance Status of >= 60\n* Patients must be able to provide informed consent\n* WBC >= 4000/mm^3\n* Platelets >= 100,000 mm^3\n* Creatinine =< 1.2 mg/dl (urinary diversion is permitted to improve renal function)\n* Patients must have bilirubin =< 1.5 mg/dl\n* Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented\n* Negative pregnancy test for women of child-bearing age\n\nExclusion\n\n* Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) [For pts that will be on definitive treatment study, otherwise delete for umbrella recurrent protocol]\n* Pregnant women, women planning to become pregnant and women that are nursing\n* Actively being treated on any other research study"
    },
    "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": "* Histologically confirmed diagnosis of NSCLC",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of NSCLC",
                    "criterion": "NSCLC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage IIIA or Potentially resectable superior sulcus tumors",
            "criterions": [
                {
                    "exact_snippets": "Stage IIIA",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IIIA"
                        }
                    ]
                },
                {
                    "exact_snippets": "Potentially resectable superior sulcus tumors",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": "potentially resectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "superior sulcus tumors",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "superior sulcus"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of distant metastatic disease as documented by MRI of the brain and PET/CT",
            "criterions": [
                {
                    "exact_snippets": "No evidence of distant metastatic disease",
                    "criterion": "distant metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "MRI of the brain",
                    "criterion": "MRI of the brain",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PET/CT",
                    "criterion": "PET/CT",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have a Karnofsky Performance Status of >= 60",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Status of >= 60",
                    "criterion": "Karnofsky Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WBC >= 4000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "WBC >= 4000/mm^3",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets >= 100,000 mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelets >= 100,000 mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine =< 1.2 mg/dl (urinary diversion is permitted to improve renal function)",
            "criterions": [
                {
                    "exact_snippets": "Creatinine =< 1.2 mg/dl",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.2,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have bilirubin =< 1.5 mg/dl",
            "criterions": [
                {
                    "exact_snippets": "bilirubin =< 1.5 mg/dl",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to use a recognized method of birth control",
                    "criterion": "use of birth control",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hysterectomy ... must be clinically documented",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "clinical documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "menopause must be clinically documented",
                    "criterion": "menopause",
                    "requirements": [
                        {
                            "requirement_type": "clinical documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative pregnancy test for women of child-bearing age",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of child-bearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "child-bearing age"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) [For pts that will be on definitive treatment study, otherwise delete for umbrella recurrent protocol]",
            "criterions": [
                {
                    "exact_snippets": "Prior or simultaneous malignancies within the past two years",
                    "criterion": "prior or simultaneous malignancies",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma",
                    "criterion": "type of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "cutaneous squamous cell carcinoma",
                                "basal cell carcinoma",
                                "melanoma in situ",
                                "thyroid carcinoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant women, women planning to become pregnant and women that are nursing",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "women planning to become pregnant",
                    "criterion": "pregnancy intention",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": "planning to become pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "women that are nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "nursing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Actively being treated on any other research study",
            "criterions": [
                {
                    "exact_snippets": "Actively being treated on any other research study",
                    "criterion": "treatment on other research study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion",
            "criterions": []
        },
        {
            "line": "Exclusion",
            "criterions": []
        }
    ]
}