{
    "info": {
        "nct_id": "NCT00953394",
        "official_title": "Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.",
        "inclusion_criteria": "* histological diagnosis of well-differentiated neuroendocrine carcinoma according to the World Health Organization (WHO) classification;\n* locally advanced or metastatic disease not amenable to surgery with radical intent;\n* at least one measurable target lesion;\n* radiological documentation of progressive disease;\n* ECOG performance status grade <=2;\n* life expectancy >12 weeks;\n* adequate bone marrow reserve;\n* adequate hepatic and renal function;\n* ability to comply with the protocol procedures (including geographic accessibility);\n* written informed consent.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* non-malignant systemic disease or conditions that precluded patients from receiving the study therapy;\n* second primary malignancies and previous systemic antineoplastic treatment including somatostatin analogues;\n* history of prior malignancy, excepted for cured non-melanoma skin cancer, and cured in situ cervical carcinoma.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* histological diagnosis of well-differentiated neuroendocrine carcinoma according to the World Health Organization (WHO) classification;",
            "criterions": [
                {
                    "exact_snippets": "histological diagnosis of well-differentiated neuroendocrine carcinoma according to the World Health Organization (WHO) classification",
                    "criterion": "well-differentiated neuroendocrine carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "classification",
                            "expected_value": "World Health Organization (WHO)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* locally advanced or metastatic disease not amenable to surgery with radical intent;",
            "criterions": [
                {
                    "exact_snippets": "locally advanced or metastatic disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to surgery with radical intent",
                    "criterion": "surgical eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* at least one measurable target lesion;",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable target lesion",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* radiological documentation of progressive disease;",
            "criterions": [
                {
                    "exact_snippets": "radiological documentation of progressive disease",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "radiological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status grade <=2;",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status grade <=2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "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": "* adequate bone marrow reserve;",
            "criterions": [
                {
                    "exact_snippets": "adequate bone marrow reserve",
                    "criterion": "bone marrow reserve",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* adequate hepatic and renal function;",
            "criterions": [
                {
                    "exact_snippets": "adequate hepatic ... function",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ability to comply with the protocol procedures (including geographic accessibility);",
            "criterions": [
                {
                    "exact_snippets": "ability to comply with the protocol procedures",
                    "criterion": "compliance with protocol procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "geographic accessibility",
                    "criterion": "geographic accessibility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* non-malignant systemic disease or conditions that precluded patients from receiving the study therapy;",
            "criterions": [
                {
                    "exact_snippets": "non-malignant systemic disease or conditions that precluded patients from receiving the study therapy",
                    "criterion": "systemic disease or conditions",
                    "requirements": [
                        {
                            "requirement_type": "malignancy",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "impact on therapy",
                            "expected_value": "precludes receiving study therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* second primary malignancies and previous systemic antineoplastic treatment including somatostatin analogues;",
            "criterions": [
                {
                    "exact_snippets": "second primary malignancies",
                    "criterion": "second primary malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "previous systemic antineoplastic treatment",
                    "criterion": "previous systemic antineoplastic treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "somatostatin analogues",
                    "criterion": "previous somatostatin analogue treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* history of prior malignancy, excepted for cured non-melanoma skin cancer, and cured in situ cervical carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "history of prior malignancy",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cured non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "cured in situ cervical carcinoma",
                    "criterion": "in situ cervical carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "cured"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}