{
    "info": {
        "nct_id": "NCT04423731",
        "official_title": "Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - a Norwegian Population Based Observational Study (NORPACT-2)",
        "inclusion_criteria": "* borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2015)\n* Nx, M0 (UICC 8 th version, 2016)\n* cytological or histological confirmation of adenocarcinoma\n* age > 18 year and considered fit for major surgery\n* written informed consent\n* considered able to receive the study-specific chemotherapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* co-morbidity precluding pancreatectomy\n* chronic neuropathy ≥ grade 2\n* WHO performance score > 2\n* granulocyte count < 1500 per cubic millimetre\n* platelet count < 100 000 per cubic millimetre\n* serum creatinine > 1.5 UNL (upper limit normal range)\n* albumin < 2,5 g/dl\n* female patients in child-bearing age not using adequate contraception, pregnant or lactating women\n* mental or physical disorders that could interfere with treatment of with the provision of informed consent\n* any reason why, in the opinion of the investigator, the patient should not participate",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2015)",
            "criterions": [
                {
                    "exact_snippets": "borderline resectable or locally advanced adenocarcinoma of the pancreas",
                    "criterion": "adenocarcinoma of the pancreas",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "borderline resectable",
                                "locally advanced"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nx, M0 (UICC 8 th version, 2016)",
            "criterions": [
                {
                    "exact_snippets": "Nx",
                    "criterion": "regional lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "unknown"
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* cytological or histological confirmation of adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "cytological or histological confirmation of adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "cytological",
                                "histological"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* age > 18 year and considered fit for major surgery",
            "criterions": [
                {
                    "exact_snippets": "age > 18 year",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "considered fit for major surgery",
                    "criterion": "fitness for major surgery",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "fit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* written informed consent",
            "criterions": [
                {
                    "exact_snippets": "written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* considered able to receive the study-specific chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "considered able to receive the study-specific chemotherapy",
                    "criterion": "ability to receive study-specific chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "* co-morbidity precluding pancreatectomy",
            "criterions": [
                {
                    "exact_snippets": "co-morbidity precluding pancreatectomy",
                    "criterion": "co-morbidity",
                    "requirements": [
                        {
                            "requirement_type": "impact on treatment",
                            "expected_value": "precluding pancreatectomy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* chronic neuropathy ≥ grade 2",
            "criterions": [
                {
                    "exact_snippets": "chronic neuropathy ≥ grade 2",
                    "criterion": "chronic neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO performance score > 2",
            "criterions": [
                {
                    "exact_snippets": "WHO performance score > 2",
                    "criterion": "WHO performance score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* granulocyte count < 1500 per cubic millimetre",
            "criterions": [
                {
                    "exact_snippets": "granulocyte count < 1500 per cubic millimetre",
                    "criterion": "granulocyte count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1500,
                                "unit": "per cubic millimetre"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* platelet count < 100 000 per cubic millimetre",
            "criterions": [
                {
                    "exact_snippets": "platelet count < 100 000 per cubic millimetre",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100000,
                                "unit": "per cubic millimetre"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* serum creatinine > 1.5 UNL (upper limit normal range)",
            "criterions": [
                {
                    "exact_snippets": "serum creatinine > 1.5 UNL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "UNL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* albumin < 2,5 g/dl",
            "criterions": [
                {
                    "exact_snippets": "albumin < 2,5 g/dl",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "g/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* female patients in child-bearing age not using adequate contraception, pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "female patients in child-bearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "child-bearing age"
                        }
                    ]
                },
                {
                    "exact_snippets": "not using adequate contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "lactating"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* mental or physical disorders that could interfere with treatment of with the provision of informed consent",
            "criterions": [
                {
                    "exact_snippets": "mental or physical disorders",
                    "criterion": "mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "interference with treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mental or physical disorders",
                    "criterion": "physical disorders",
                    "requirements": [
                        {
                            "requirement_type": "interference with treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mental or physical disorders ... interfere ... with the provision of informed consent",
                    "criterion": "mental disorders",
                    "requirements": [
                        {
                            "requirement_type": "interference with informed consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mental or physical disorders ... interfere ... with the provision of informed consent",
                    "criterion": "physical disorders",
                    "requirements": [
                        {
                            "requirement_type": "interference with informed consent",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* any reason why, in the opinion of the investigator, the patient should not participate",
            "criterions": [
                {
                    "exact_snippets": "any reason why, in the opinion of the investigator, the patient should not participate",
                    "criterion": "investigator's opinion on participation",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "no reason to exclude"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}