{
    "info": {
        "nct_id": "NCT00057876",
        "official_title": "A Randomized Phase III Study Of Gemcitabine In Combination With Radiation Therapy Versus Gemcitabine Alone In Patients With Localized, Unresectable Pancreatic Cancer",
        "inclusion_criteria": "* Histologically or cytologically confirmed adenocarcinoma of the pancreas\n\n  * Locally advanced or regional (encompassable within the same radiotherapy portals)\n  * Adenosquamous cancers are allowed\n* Unresectable disease\n* Measurable and/or non-measurable disease as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks prior to randomization.\n* Age>=18\n* ECOG Performance status of 0-1\n* Life expectancy >= 12 weeks\n* Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization:\n\n  * Absolute granulocyte count at least 2,000/mm^3\n  * Platelet count at least 100,000/mm^3\n  * Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)\n  * Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN)\n  * Albumin greater than 2.5 g/dL\n  * Creatinine no greater than 1.5 times ULN\n* Fertile patients must use effective contraception\n* Willing and able to attend follow-up visits\n* Concurrent enrollment on protocol ECOG-E1Y03 allowed\n* More than 4 weeks since prior investigational agents\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)\n* Stage M1 disease\n* Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology\n* Pregnant or nursing\n* Active infection within within 4 weeks of randomization\n* Malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7)\n* History of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)\n* Signs or symptoms of peptic or duodenal ulcer disease\n* Concurrent serious systemic disorders that are incompatible with study participation\n* Prior chemotherapy for pancreatic cancer\n* Prior radiotherapy\n* Concurrent intensity modulated radiotherapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed adenocarcinoma of the pancreas",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed adenocarcinoma of the pancreas",
                    "criterion": "adenocarcinoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced or regional (encompassable within the same radiotherapy portals)",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced or regional",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "regional"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "encompassable within the same radiotherapy portals",
                    "criterion": "radiotherapy portal suitability",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adenosquamous cancers are allowed",
            "criterions": [
                {
                    "exact_snippets": "Adenosquamous cancers are allowed",
                    "criterion": "adenosquamous cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unresectable disease",
            "criterions": [
                {
                    "exact_snippets": "Unresectable disease",
                    "criterion": "disease resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable and/or non-measurable disease as determined by computed tomography (CT) scan or magnetic resonance imaging (MRI), which must be performed within 4 weeks prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Measurable and/or non-measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "measurable",
                                "non-measurable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "determined by computed tomography (CT) scan or magnetic resonance imaging (MRI)",
                    "criterion": "imaging method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "computed tomography (CT) scan",
                                "magnetic resonance imaging (MRI)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "performed within 4 weeks prior to randomization",
                    "criterion": "imaging timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age>=18",
            "criterions": [
                {
                    "exact_snippets": "Age>=18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance status of 0-1",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance status of 0-1",
                    "criterion": "ECOG Performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy >= 12 weeks",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy >= 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute granulocyte count at least 2,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Absolute granulocyte count at least 2,000/mm^3",
                    "criterion": "absolute granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count at least 100,000/mm^3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count at least 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin less than 3 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless secondary to biliary obstruction or cholangitis",
                    "criterion": "bilirubin level exception",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": [
                                "biliary obstruction",
                                "cholangitis"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Serum glutamic-oxaloacetic (AST) less than 5 times upper limit of normal (ULN)",
                    "criterion": "serum glutamic-oxaloacetic (AST)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Albumin greater than 2.5 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Albumin greater than 2.5 g/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine no greater than 1.5 times ULN",
            "criterions": [
                {
                    "exact_snippets": "Creatinine no greater than 1.5 times ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use effective contraception",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing and able to attend follow-up visits",
            "criterions": [
                {
                    "exact_snippets": "Willing and able to attend follow-up visits",
                    "criterion": "attendance at follow-up visits",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent enrollment on protocol ECOG-E1Y03 allowed",
            "criterions": [
                {
                    "exact_snippets": "Concurrent enrollment on protocol ECOG-E1Y03 allowed",
                    "criterion": "enrollment on protocol ECOG-E1Y03",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 4 weeks since prior investigational agents",
            "criterions": [
                {
                    "exact_snippets": "More than 4 weeks since prior investigational agents",
                    "criterion": "time since prior investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0)",
            "criterions": [
                {
                    "exact_snippets": "Candidate for surgical excision",
                    "criterion": "surgical excision candidacy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "local extent of disease (e.g., T3, N1, M0)",
                    "criterion": "local extent of disease",
                    "requirements": [
                        {
                            "requirement_type": "staging",
                            "expected_value": [
                                "T3",
                                "N1",
                                "M0"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Stage M1 disease",
            "criterions": [
                {
                    "exact_snippets": "Stage M1 disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "M1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Small cell, mucinous cystadenocarcinoma, islet cell or papillary cystic histology",
            "criterions": [
                {
                    "exact_snippets": "Small cell",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "small cell"
                        }
                    ]
                },
                {
                    "exact_snippets": "mucinous cystadenocarcinoma",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "mucinous cystadenocarcinoma"
                        }
                    ]
                },
                {
                    "exact_snippets": "islet cell",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "islet cell"
                        }
                    ]
                },
                {
                    "exact_snippets": "papillary cystic histology",
                    "criterion": "histology",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "papillary cystic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection within within 4 weeks of randomization",
            "criterions": [
                {
                    "exact_snippets": "Active infection within within 4 weeks of randomization",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks of randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7)",
            "criterions": [
                {
                    "exact_snippets": "Malignancy within the past 5 years",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "nonmelanoma skin cancer",
                    "criterion": "nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "organ-confined prostate cancer (Gleason score no greater than 7)",
                    "criterion": "organ-confined prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "Gleason score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma)",
            "criterions": [
                {
                    "exact_snippets": "History of active collagen vascular disease",
                    "criterion": "active collagen vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic lupus erythematosus",
                    "criterion": "systemic lupus erythematosus",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rheumatoid arthritis",
                    "criterion": "rheumatoid arthritis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "scleroderma",
                    "criterion": "scleroderma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signs or symptoms of peptic or duodenal ulcer disease",
            "criterions": [
                {
                    "exact_snippets": "Signs or symptoms of peptic or duodenal ulcer disease",
                    "criterion": "peptic or duodenal ulcer disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent serious systemic disorders that are incompatible with study participation",
            "criterions": [
                {
                    "exact_snippets": "Concurrent serious systemic disorders",
                    "criterion": "serious systemic disorders",
                    "requirements": [
                        {
                            "requirement_type": "compatibility with study participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy for pancreatic cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy for pancreatic cancer",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "pancreatic cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Prior radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent intensity modulated radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "Concurrent intensity modulated radiotherapy",
                    "criterion": "intensity modulated radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization:",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow reserve",
                    "criterion": "bone marrow reserve",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... liver ... function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}