{
    "info": {
        "nct_id": "NCT02125448",
        "official_title": "Preoperative Identification of Response to Neoadjuvant Chemoradiotherapy for Esophageal Cancer (PRIOR)",
        "inclusion_criteria": "* Histologically confirmed squamous-cell carcinoma, adenocarcinoma or large-cell undifferentiated carcinoma of the esophagus or esophagogastric junction (i.e. tumors involving both cardia and esophagus on endoscopy)\n* Potentially resectable tumor (cT1b-4a N0-3 M0): based on standard primary staging by EUS and CT\n* Undergoing preoperative chemoradiation according to CROSS-regimen\n* Age>18 years\n* No history of other cancer or previous radiotherapy or chemotherapy\n* Signed informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who meet exclusion criteria for MRI at 1.5T following the protocol of the department of Radiology of the UMC Utrecht\n* Patients who meet exclusion criteria for intravenous contrast (Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2, unless the patient has risk factors for contrast nephropathy according to the UMC Utrecht protocol 'Prevention contrast reaction and contrast nephropathy, Version 2 February 2012'). In patients with risk factors (2 or more of the following: 'peripheral vascular disease, heart failure, age >75 years, anemia, symptomatic hypotension, dehydration, use of diuretics or non-steroidal anti-inflammatory drugs)', a minimum GFR of 60 mL/min/1.73m2 will be required\n* Patients with insulin dependent diabetes mellitus or blood plasma glucose concentration higher than 10 mmol/L\n* Patients with a known Gadovist allergy\n* Patients with a known CT-contrast allergy\n* Patients having difficulty understanding Dutch\n* Pregnant or breast-feeding patients",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed squamous-cell carcinoma, adenocarcinoma or large-cell undifferentiated carcinoma of the esophagus or esophagogastric junction (i.e. tumors involving both cardia and esophagus on endoscopy)",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed squamous-cell carcinoma",
                    "criterion": "squamous-cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically confirmed ... large-cell undifferentiated carcinoma",
                    "criterion": "large-cell undifferentiated carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinoma of the esophagus or esophagogastric junction",
                    "criterion": "carcinoma location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "esophagus",
                                "esophagogastric junction"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors involving both cardia and esophagus on endoscopy",
                    "criterion": "tumor involvement",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": "both cardia and esophagus on endoscopy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Potentially resectable tumor (cT1b-4a N0-3 M0): based on standard primary staging by EUS and CT",
            "criterions": [
                {
                    "exact_snippets": "Potentially resectable tumor",
                    "criterion": "tumor resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": "potentially resectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "cT1b-4a",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1.1,
                                        "unit": "cT"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4.0,
                                        "unit": "cT"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0-3",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "M"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "based on standard primary staging by EUS and CT",
                    "criterion": "staging method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "EUS",
                                "CT"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Undergoing preoperative chemoradiation according to CROSS-regimen",
            "criterions": [
                {
                    "exact_snippets": "Undergoing preoperative chemoradiation according to CROSS-regimen",
                    "criterion": "preoperative chemoradiation",
                    "requirements": [
                        {
                            "requirement_type": "protocol",
                            "expected_value": "CROSS-regimen"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age>18 years",
            "criterions": [
                {
                    "exact_snippets": "Age>18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No history of other cancer or previous radiotherapy or chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "No history of other cancer",
                    "criterion": "history of other cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of ... previous radiotherapy",
                    "criterion": "history of previous radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of ... previous ... chemotherapy",
                    "criterion": "history of previous chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "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": "* Patients who meet exclusion criteria for MRI at 1.5T following the protocol of the department of Radiology of the UMC Utrecht",
            "criterions": [
                {
                    "exact_snippets": "exclusion criteria for MRI at 1.5T",
                    "criterion": "MRI exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who meet exclusion criteria for intravenous contrast (Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2, unless the patient has risk factors for contrast nephropathy according to the UMC Utrecht protocol 'Prevention contrast reaction and contrast nephropathy, Version 2 February 2012'). In patients with risk factors (2 or more of the following: 'peripheral vascular disease, heart failure, age >75 years, anemia, symptomatic hypotension, dehydration, use of diuretics or non-steroidal anti-inflammatory drugs)', a minimum GFR of 60 mL/min/1.73m2 will be required",
            "criterions": [
                {
                    "exact_snippets": "Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2",
                    "criterion": "Glomerular Filtration Rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 45,
                                "unit": "mL/min/1.73m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "risk factors for contrast nephropathy",
                    "criterion": "risk factors for contrast nephropathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "peripheral vascular disease",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "age >75 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 75,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "anemia",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic hypotension",
                    "criterion": "symptomatic hypotension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dehydration",
                    "criterion": "dehydration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of diuretics",
                    "criterion": "use of diuretics",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of ... non-steroidal anti-inflammatory drugs",
                    "criterion": "use of non-steroidal anti-inflammatory drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "minimum GFR of 60 mL/min/1.73m2",
                    "criterion": "Glomerular Filtration Rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min/1.73m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with insulin dependent diabetes mellitus or blood plasma glucose concentration higher than 10 mmol/L",
            "criterions": [
                {
                    "exact_snippets": "insulin dependent diabetes mellitus",
                    "criterion": "diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "insulin dependent"
                        }
                    ]
                },
                {
                    "exact_snippets": "blood plasma glucose concentration higher than 10 mmol/L",
                    "criterion": "blood plasma glucose concentration",
                    "requirements": [
                        {
                            "requirement_type": "concentration",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mmol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a known Gadovist allergy",
            "criterions": [
                {
                    "exact_snippets": "known Gadovist allergy",
                    "criterion": "Gadovist allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a known CT-contrast allergy",
            "criterions": [
                {
                    "exact_snippets": "known CT-contrast allergy",
                    "criterion": "CT-contrast allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients having difficulty understanding Dutch",
            "criterions": [
                {
                    "exact_snippets": "difficulty understanding Dutch",
                    "criterion": "understanding Dutch",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast-feeding patients",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}