{
    "info": {
        "nct_id": "NCT02843191",
        "official_title": "KCSP Trial of CONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After NeoadjUvant Concurrent ChemoraDiothErapy: a Multicenter, Randomized Controlled Trial (KONCLUDE)",
        "inclusion_criteria": "1. Histologically confirmed adenocarcinoma of mid or low rectum\n2. Locally advanced rectal cancer confirmed by image (i.e. Magnetic resonance image)\n\n   * Clinical stage T1-3N1or2 on MRI\n   * Clinical stage cT3N0 (or depth of perirectal invasion by tumor >5mm on MRI)\n   * Suspicious of circumferential invasion on MRI (or circumferential margin <1mm)\n3. ECOG performance status of 0-2\n4. ASA grade ≤ 3\n5. An informed consent has been signed by the patient\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Upper rectal cancer\n2. Clinical stage T1or2N0 on MRI\n3. Clinical stage T4Nany on MRI\n4. Clinical stage TanyNanyM1 by image or histology\n5. The patient received chemotherapy or radiotherapy during the past 6 months\n6. The patient received any therapy for colorectal cancer or another malignancy during the past 5 years\n7. The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy\n8. Pregnant of breastfeeding women\n9. The patient who participate in another clinical trial, or receives any drug for the trial\n10. Uncontrolled peripheral neuropathy (more than grade 2)\n11. Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess\n12. Active gastrointestinal bleeding\n13. Patients with an active infection, which needs antibiotic therapy, during the randomization period",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Histologically confirmed adenocarcinoma of mid or low rectum",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma",
                    "criterion": "adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "mid or low rectum",
                    "criterion": "location of adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "mid rectum",
                                "low rectum"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Locally advanced rectal cancer confirmed by image (i.e. Magnetic resonance image)",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced rectal cancer confirmed by image (i.e. Magnetic resonance image)",
                    "criterion": "rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        },
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "image (i.e. Magnetic resonance image)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical stage T1-3N1or2 on MRI",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage T1-3",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N1or2 on MRI",
                    "criterion": "nodal involvement",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical stage cT3N0 (or depth of perirectal invasion by tumor >5mm on MRI)",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage cT3N0",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "cT3N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "depth of perirectal invasion by tumor >5mm on MRI",
                    "criterion": "depth of perirectal invasion by tumor",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suspicious of circumferential invasion on MRI (or circumferential margin <1mm)",
            "criterions": [
                {
                    "exact_snippets": "Suspicious of circumferential invasion on MRI",
                    "criterion": "circumferential invasion",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "circumferential margin <1mm",
                    "criterion": "circumferential margin",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. ECOG performance status of 0-2",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 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": "4. ASA grade ≤ 3",
            "criterions": [
                {
                    "exact_snippets": "ASA grade ≤ 3",
                    "criterion": "ASA grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. An informed consent has been signed by the patient",
            "criterions": [
                {
                    "exact_snippets": "An informed consent has been signed by the patient",
                    "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 20 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 20 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Upper rectal cancer",
            "criterions": [
                {
                    "exact_snippets": "Upper rectal cancer",
                    "criterion": "rectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "upper"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Clinical stage T1or2N0 on MRI",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage T1or2N0 on MRI",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "T2"
                            ]
                        },
                        {
                            "requirement_type": "node involvement",
                            "expected_value": "N0"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Clinical stage T4Nany on MRI",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage T4",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T4"
                        }
                    ]
                },
                {
                    "exact_snippets": "Nany on MRI",
                    "criterion": "nodal involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Clinical stage TanyNanyM1 by image or histology",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage TanyNanyM1",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "TanyNanyM1"
                        }
                    ]
                },
                {
                    "exact_snippets": "by image",
                    "criterion": "diagnostic method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "image"
                        }
                    ]
                },
                {
                    "exact_snippets": "by ... histology",
                    "criterion": "diagnostic method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histology"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The patient received chemotherapy or radiotherapy during the past 6 months",
            "criterions": [
                {
                    "exact_snippets": "received chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "received ... radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. The patient received any therapy for colorectal cancer or another malignancy during the past 5 years",
            "criterions": [
                {
                    "exact_snippets": "The patient received any therapy for colorectal cancer",
                    "criterion": "therapy for colorectal cancer",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the past 5 years"
                        }
                    ]
                },
                {
                    "exact_snippets": "The patient received any therapy for ... another malignancy",
                    "criterion": "therapy for another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the past 5 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "severe underlying diseases",
                    "criterion": "underlying diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "poor condition to receive chemotherapy or radiotherapy",
                    "criterion": "condition to receive chemotherapy or radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "poor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Pregnant of breastfeeding women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding women",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. The patient who participate in another clinical trial, or receives any drug for the trial",
            "criterions": [
                {
                    "exact_snippets": "The patient who participate in another clinical trial",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "receives any drug for the trial",
                    "criterion": "receiving any drug for the trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Uncontrolled peripheral neuropathy (more than grade 2)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled peripheral neuropathy (more than grade 2)",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess",
            "criterions": [
                {
                    "exact_snippets": "unhealed wound",
                    "criterion": "wound",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        }
                    ]
                },
                {
                    "exact_snippets": "unhealed ... fracture",
                    "criterion": "fracture",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        }
                    ]
                },
                {
                    "exact_snippets": "unhealed ... peptic ulcer",
                    "criterion": "peptic ulcer",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        }
                    ]
                },
                {
                    "exact_snippets": "unhealed ... intraabdominal abscess",
                    "criterion": "intraabdominal abscess",
                    "requirements": [
                        {
                            "requirement_type": "healing status",
                            "expected_value": "unhealed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Active gastrointestinal bleeding",
            "criterions": [
                {
                    "exact_snippets": "Active gastrointestinal bleeding",
                    "criterion": "gastrointestinal bleeding",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Patients with an active infection, which needs antibiotic therapy, during the randomization period",
            "criterions": [
                {
                    "exact_snippets": "Patients with an active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "which needs antibiotic therapy",
                    "criterion": "antibiotic therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the randomization period",
                    "criterion": "randomization period",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}