{
    "info": {
        "nct_id": "NCT03937362",
        "official_title": "Accuracy of Detecting Residual Disease After Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma: the preSINO Trial (Pre-Surgery If Needed for Oesophageal Cancer)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 20 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria are:\n\n1. Histologically confirmed esophageal squamous cell carcinoma;\n2. Tumor located in the chest;\n3. Clinical stage cT1N1-2M0, cT2-4aN0-2M0, according to the 8th Edition of the AJCC TNM classification for Esophageal Cancer;\n4. Age > 20 at the date of informed consent;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of two or less;\n6. Considered fit to undergo nCRT followed by surgical resection;\n7. Expected survival time more than three months;\n8. Written informed consent by the patient.\n\nExclusion criteria are:\n\n1. Patient with a second primary tumor;\n2. Previous major surgery in the chest or upper abdomen;\n3. Tumor not 18F-FDG-avid at baseline PET-CT;\n4. Suspected positive lymph nodes that cannot be covered by an uninterrupted radiation field that also includes the primary tumor area;\n5. Primary (early) lesion already removed by EMR/ESD;\n6. Previous history of chemotherapy and/or radiation therapy;\n7. Cervical esophageal cancer."
    },
    "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 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. Histologically confirmed esophageal squamous cell carcinoma;",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed esophageal squamous cell carcinoma",
                    "criterion": "esophageal squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Tumor located in the chest;",
            "criterions": [
                {
                    "exact_snippets": "Tumor located in the chest",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "chest"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Clinical stage cT1N1-2M0, cT2-4aN0-2M0, according to the 8th Edition of the AJCC TNM classification for Esophageal Cancer;",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage cT1N1-2M0, cT2-4aN0-2M0, according to the 8th Edition of the AJCC TNM classification for Esophageal Cancer",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "cT1N1-2M0, cT2-4aN0-2M0"
                        },
                        {
                            "requirement_type": "classification system",
                            "expected_value": "8th Edition of the AJCC TNM classification for Esophageal Cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Age > 20 at the date of informed consent;",
            "criterions": [
                {
                    "exact_snippets": "Age > 20",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Eastern Cooperative Oncology Group (ECOG) Performance Status of two or less;",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status of two or less",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Considered fit to undergo nCRT followed by surgical resection;",
            "criterions": [
                {
                    "exact_snippets": "Considered fit to undergo nCRT",
                    "criterion": "fitness for nCRT",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Considered fit to undergo ... surgical resection",
                    "criterion": "fitness for surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Expected survival time more than three months;",
            "criterions": [
                {
                    "exact_snippets": "Expected survival time more than three months",
                    "criterion": "expected survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Written informed consent by the patient.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent by the patient.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Patient with a second primary tumor;",
            "criterions": [
                {
                    "exact_snippets": "second primary tumor",
                    "criterion": "second primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Previous major surgery in the chest or upper abdomen;",
            "criterions": [
                {
                    "exact_snippets": "Previous major surgery in the chest",
                    "criterion": "major surgery in the chest",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous major surgery in the ... upper abdomen",
                    "criterion": "major surgery in the upper abdomen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Tumor not 18F-FDG-avid at baseline PET-CT;",
            "criterions": [
                {
                    "exact_snippets": "Tumor not 18F-FDG-avid",
                    "criterion": "tumor 18F-FDG avidity",
                    "requirements": [
                        {
                            "requirement_type": "avidity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Suspected positive lymph nodes that cannot be covered by an uninterrupted radiation field that also includes the primary tumor area;",
            "criterions": [
                {
                    "exact_snippets": "Suspected positive lymph nodes",
                    "criterion": "lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "suspected positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot be covered by an uninterrupted radiation field",
                    "criterion": "radiation field coverage",
                    "requirements": [
                        {
                            "requirement_type": "coverage",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "includes the primary tumor area",
                    "criterion": "radiation field coverage",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": "primary tumor area"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Primary (early) lesion already removed by EMR/ESD;",
            "criterions": [
                {
                    "exact_snippets": "Primary (early) lesion already removed by EMR/ESD",
                    "criterion": "primary (early) lesion",
                    "requirements": [
                        {
                            "requirement_type": "removal",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Previous history of chemotherapy and/or radiation therapy;",
            "criterions": [
                {
                    "exact_snippets": "Previous history of chemotherapy",
                    "criterion": "chemotherapy history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous history of ... radiation therapy",
                    "criterion": "radiation therapy history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Cervical esophageal cancer.",
            "criterions": [
                {
                    "exact_snippets": "Cervical esophageal cancer",
                    "criterion": "cervical esophageal cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion criteria are:",
            "criterions": []
        },
        {
            "line": "Exclusion criteria are:",
            "criterions": []
        }
    ]
}