{
    "info": {
        "nct_id": "NCT00425360",
        "official_title": "A Prospective, Phase III, Controlled, Multicentre, Randomised Clinical Trial Comparing Combination Gemcitabine and Capecitabine Therapy With Concurrent and Sequential Chemoimmunotherapy Using a Telomerase Vaccine in Locally Advanced and Metastatic Pancreatic Cancer [TELOVAC]",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas\n\n  * Locally advanced or metastatic disease precluding curative surgical resection\n* Unidimensionally measurable disease by CT scan\n* No intracerebral metastases or meningeal carcinomatosis\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Life expectancy > 3 months\n* WBC > 3,000/mm³\n* Absolute neutrophil count > 1,500/mm³\n* Platelet count > 100,000/mm³\n* Bilirubin < 2.0 mg/dL\n* Creatinine clearance > 50 mL/min\n* No medical or psychiatric condition that would preclude giving informed consent\n* No clinically significant serious disease or organ system disease not currently controlled on present therapy\n* No uncontrolled angina pectoris\n* Not pregnant or nursing\n* Fertile patients must use a condom and ≥ 1 other form of contraception during and for 1 year after completion of study treatment\n* No other malignancies or invasive cancers within the past 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix\n* No known malabsorption syndrome\n* No known hypersensitivity to any of the investigational agents\n* No dihydropyrimidine dehydrogenase deficiency\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy\n* No radiotherapy within the past 4 weeks\n* No concurrent medications that could affect immunocompetence (e.g., chronic treatment with long-term steroids or other immunosuppressants for unrelated condition)\n\n  * Concurrent short-term steroids for palliation of cancer-related symptoms allowed\n* No other concurrent investigational drugs or cytotoxic agents\n* No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids) or chemotherapy for another tumor in patients receiving telomerase peptide vaccine GV1001\n\n  * Concurrent low-dose corticosteroids may be allowed"
    },
    "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": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed pancreatic ductal adenocarcinoma",
                    "criterion": "pancreatic ductal adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically or cytologically confirmed ... undifferentiated carcinoma of the pancreas",
                    "criterion": "undifferentiated carcinoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced or metastatic disease precluding curative surgical resection",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced or metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "precluding curative surgical resection",
                    "criterion": "surgical resection eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unidimensionally measurable disease by CT scan",
            "criterions": [
                {
                    "exact_snippets": "Unidimensionally measurable disease by CT scan",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": "unidimensional"
                        },
                        {
                            "requirement_type": "method",
                            "expected_value": "CT scan"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No intracerebral metastases or meningeal carcinomatosis",
            "criterions": [
                {
                    "exact_snippets": "No intracerebral metastases",
                    "criterion": "intracerebral metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... meningeal carcinomatosis",
                    "criterion": "meningeal carcinomatosis",
                    "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": "* 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": "* WBC > 3,000/mm³",
            "criterions": [
                {
                    "exact_snippets": "WBC > 3,000/mm³",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 3000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count > 1,500/mm³",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count > 1,500/mm³",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1500,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count > 100,000/mm³",
            "criterions": [
                {
                    "exact_snippets": "Platelet count > 100,000/mm³",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "mm³"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin < 2.0 mg/dL",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin < 2.0 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance > 50 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance > 50 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No medical or psychiatric condition that would preclude giving informed consent",
            "criterions": [
                {
                    "exact_snippets": "No medical or psychiatric condition that would preclude giving informed consent",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No medical or psychiatric condition that would preclude giving informed consent",
                    "criterion": "psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No clinically significant serious disease or organ system disease not currently controlled on present therapy",
            "criterions": [
                {
                    "exact_snippets": "No clinically significant serious disease",
                    "criterion": "clinically significant serious disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... organ system disease not currently controlled on present therapy",
                    "criterion": "organ system disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No uncontrolled angina pectoris",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile patients must use a condom and ≥ 1 other form of contraception during and for 1 year after completion of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Fertile patients",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "must use a condom",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "condom"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 1 other form of contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": ">= 1 other form"
                        }
                    ]
                },
                {
                    "exact_snippets": "during and for 1 year after completion of study treatment",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during and for 1 year after completion of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other malignancies or invasive cancers within the past 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix",
            "criterions": [
                {
                    "exact_snippets": "No other malignancies or invasive cancers within the past 5 years",
                    "criterion": "other malignancies or invasive cancers",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for adequately treated basal cell carcinoma of the skin",
                    "criterion": "basal cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... carcinoma in situ of the cervix",
                    "criterion": "carcinoma in situ of the cervix",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known malabsorption syndrome",
            "criterions": [
                {
                    "exact_snippets": "No known malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known hypersensitivity to any of the investigational agents",
            "criterions": [
                {
                    "exact_snippets": "No known hypersensitivity to any of the investigational agents",
                    "criterion": "hypersensitivity to investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No dihydropyrimidine dehydrogenase deficiency",
            "criterions": [
                {
                    "exact_snippets": "No dihydropyrimidine dehydrogenase deficiency",
                    "criterion": "dihydropyrimidine dehydrogenase deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No radiotherapy within the past 4 weeks",
            "criterions": [
                {
                    "exact_snippets": "No radiotherapy within the past 4 weeks",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent medications that could affect immunocompetence (e.g., chronic treatment with long-term steroids or other immunosuppressants for unrelated condition)",
            "criterions": [
                {
                    "exact_snippets": "No concurrent medications that could affect immunocompetence",
                    "criterion": "concurrent medications affecting immunocompetence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic treatment with long-term steroids",
                    "criterion": "chronic treatment with long-term steroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunosuppressants for unrelated condition",
                    "criterion": "other immunosuppressants for unrelated condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent short-term steroids for palliation of cancer-related symptoms allowed",
            "criterions": [
                {
                    "exact_snippets": "Concurrent short-term steroids for palliation of cancer-related symptoms allowed",
                    "criterion": "concurrent short-term steroids",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "palliation of cancer-related symptoms"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent investigational drugs or cytotoxic agents",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent investigational drugs",
                    "criterion": "concurrent investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent ... cytotoxic agents",
                    "criterion": "concurrent cytotoxic agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids) or chemotherapy for another tumor in patients receiving telomerase peptide vaccine GV1001",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids)",
                    "criterion": "concurrent immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent ... chemotherapy for another tumor",
                    "criterion": "concurrent chemotherapy for another tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent low-dose corticosteroids may be allowed",
            "criterions": [
                {
                    "exact_snippets": "Concurrent low-dose corticosteroids may be allowed",
                    "criterion": "concurrent low-dose corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        },
        {
            "line": "* Not pregnant or nursing",
            "criterions": [
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not ... nursing",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ]
}