{
    "info": {
        "nct_id": "NCT01693276",
        "official_title": "Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer",
        "inclusion_criteria": "* Histologically or cytologically proven carcinoma of the pancreas that is locally advanced\n* ECOG performance status 0- 2\n* Adequate labs\n* No prior abdominal radiation therapy\n* No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years\n* All disease must be encompassed within a radiotherapy portal\n* Not pregnant or nursing\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patient has metastatic disease on radiological staging\n* systemic therapy.\n* Patient has known active infection with HIV, hepatitis C or hepatitis B\n* Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.\n* Patient is deemed to be have obvious resectable disease at presentation\n* Received any investigational agent within a month prior to enrollment.\n* Neuroendocrine tumors of the pancreas",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically proven carcinoma of the pancreas that is locally advanced",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically proven carcinoma of the pancreas",
                    "criterion": "carcinoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced",
                    "criterion": "carcinoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Adequate labs",
            "criterions": [
                {
                    "exact_snippets": "Adequate labs",
                    "criterion": "laboratory results",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior abdominal radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "No prior abdominal radiation therapy",
                    "criterion": "abdominal radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other concurrent clinically evident malignancy, except inactive nonmelanoma skin cancer, inactive cervical cancer, or other cancer for which the patient has been disease-free for 5 years",
            "criterions": [
                {
                    "exact_snippets": "No other concurrent clinically evident malignancy",
                    "criterion": "concurrent clinically evident malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "except inactive nonmelanoma skin cancer",
                    "criterion": "inactive nonmelanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... inactive cervical cancer",
                    "criterion": "inactive cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except ... other cancer for which the patient has been disease-free for 5 years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All disease must be encompassed within a radiotherapy portal",
            "criterions": [
                {
                    "exact_snippets": "All disease must be encompassed within a radiotherapy portal",
                    "criterion": "disease location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "within a radiotherapy portal"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patient has metastatic disease on radiological staging",
            "criterions": [
                {
                    "exact_snippets": "metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiological staging",
                    "criterion": "radiological staging",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "radiological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "systemic therapy",
                    "criterion": "systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has known active infection with HIV, hepatitis C or hepatitis B",
            "criterions": [
                {
                    "exact_snippets": "known active infection with HIV",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known active infection with ... hepatitis C",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known active infection with ... hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug.",
            "criterions": [
                {
                    "exact_snippets": "serious medical risk factors involving any of the major organ systems",
                    "criterion": "medical risk factors",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "involvement",
                            "expected_value": "major organ systems"
                        }
                    ]
                },
                {
                    "exact_snippets": "Investigator considers it unsafe for the patient to receive an experimental research drug",
                    "criterion": "safety for receiving experimental research drug",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "unsafe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is deemed to be have obvious resectable disease at presentation",
            "criterions": [
                {
                    "exact_snippets": "obvious resectable disease",
                    "criterion": "disease resectability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received any investigational agent within a month prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Received any investigational agent within a month prior to enrollment.",
                    "criterion": "investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Neuroendocrine tumors of the pancreas",
            "criterions": [
                {
                    "exact_snippets": "Neuroendocrine tumors of the pancreas",
                    "criterion": "neuroendocrine tumors",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "pancreas"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "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
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}