{
    "info": {
        "nct_id": "NCT04889820",
        "official_title": "Oncologic oUTcomes of Neoadjuvant Chemotherapy for obSTructive Colon cAncer After steNt Decompression (OUTSTAND Trial); Multicenter Randomized Controlled Trial",
        "inclusion_criteria": "* i. Age : 20 years old or more and lesser than 75 years old ii. Agreement of this study iii. Clinical stage II or III colon cancer with colonic obstruction which is confirmed by pathologic review and imaging study.\n\niv. Colon cancer located beween distal T colon and Rectosigmoid junction colon which is defined as a tumor above 15cm from anal verge.\n\nv. Colonocopic fiding: tumor involving whole circumference of the lumen, impossible to pass endoscope through the tumor vi. SEMS placement vii. no colonic injury and successful decompression of the colon with in 48 hours after SEMS placement.\n\nviii. ECOG performance 0-2 ix. ASA ≤ 3 x. Appropriate function of the vital organ (acceptable liver enzyme and BUN/Cr) xi. Appropriate function of hematopoietic system (platelet ≥100,000ul, neutrophil ≥2,000ul) xii. If the patient is female in fertile period, urine hCG test is negative and she has no plan of pregnancy with 6 months after the termiation of whole treatment.\n\nxiii. If the patient is male in fertile period, he agrees with contraception during treatment period and 6 months after the termination of whole treatment.\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 74 Years",
        "exclusion_criteria": "* i. any suspicious distant metastasis ii. any other primary malignant lesion iii. Clinical stage T1or T2 and N0 iv. the sign of perforation or severe ischemia requiring ememgency operation v. the complication related to SEMS placement (severe bleeding and perforation after SEMS placement) vi. ASA 4 or more vii. ECOG 3 or more viii. colonic obstruction by benign stricture ix. pregnant woman or woman who is breastfeeding x. the paitents who already enrolled into other study or are taking medicine related to any clinical trial xi. the patients who are taking sorivudine xii. the patients who are taking Tegafur/gimeracil/oteracil xiii. the patietns who have a medical history of hypersensitivity reaction to 5-FU, oxaliplatin, leucovorin,or any medication including platinum.\n\nxiv. Inappropriate function of vital organ (impaired renal function, elevated liver enzyme, and so on ) xv. Inappropriate function of hematopoietic system (platelet <100,000ul, neutrophil < 2,000ul) xvi. Genetic problem such as galactose intolerance, Lapp lactase deficiency, or glucose-galatose malabsorption)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* i. Age : 20 years old or more and lesser than 75 years old ii. Agreement of this study iii. Clinical stage II or III colon cancer with colonic obstruction which is confirmed by pathologic review and imaging study.",
            "criterions": [
                {
                    "exact_snippets": "Age : 20 years old or more and lesser than 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 20,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Agreement of this study",
                    "criterion": "study agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical stage II or III colon cancer",
                    "criterion": "colon cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "II",
                                "III"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "colonic obstruction",
                    "criterion": "colonic obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "confirmed by pathologic review and imaging study",
                    "criterion": "confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "pathologic review",
                                "imaging study"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "iv. Colon cancer located beween distal T colon and Rectosigmoid junction colon which is defined as a tumor above 15cm from anal verge.",
            "criterions": [
                {
                    "exact_snippets": "Colon cancer located beween distal T colon and Rectosigmoid junction colon",
                    "criterion": "colon cancer location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "between distal T colon and Rectosigmoid junction colon"
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor above 15cm from anal verge",
                    "criterion": "tumor location",
                    "requirements": [
                        {
                            "requirement_type": "distance from anal verge",
                            "expected_value": {
                                "operator": ">",
                                "value": 15,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "v. Colonocopic fiding: tumor involving whole circumference of the lumen, impossible to pass endoscope through the tumor vi. SEMS placement vii. no colonic injury and successful decompression of the colon with in 48 hours after SEMS placement.",
            "criterions": [
                {
                    "exact_snippets": "Colonocopic fiding: tumor involving whole circumference of the lumen",
                    "criterion": "tumor involvement",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": "whole circumference of the lumen"
                        }
                    ]
                },
                {
                    "exact_snippets": "impossible to pass endoscope through the tumor",
                    "criterion": "endoscope passage",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "SEMS placement",
                    "criterion": "SEMS placement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no colonic injury",
                    "criterion": "colonic injury",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "successful decompression of the colon with in 48 hours after SEMS placement",
                    "criterion": "colon decompression",
                    "requirements": [
                        {
                            "requirement_type": "success",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 48,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "viii. ECOG performance 0-2 ix. ASA ≤ 3 x. Appropriate function of the vital organ (acceptable liver enzyme and BUN/Cr) xi. Appropriate function of hematopoietic system (platelet ≥100,000ul, neutrophil ≥2,000ul) xii. If the patient is female in fertile period, urine hCG test is negative and she has no plan of pregnancy with 6 months after the termiation of whole treatment.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance 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"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ASA ≤ 3",
                    "criterion": "ASA physical status classification",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Appropriate function of the vital organ (acceptable liver enzyme and BUN/Cr)",
                    "criterion": "vital organ function",
                    "requirements": [
                        {
                            "requirement_type": "function",
                            "expected_value": "acceptable liver enzyme and BUN/Cr"
                        }
                    ]
                },
                {
                    "exact_snippets": "Appropriate function of hematopoietic system (platelet ≥100,000ul, neutrophil ≥2,000ul)",
                    "criterion": "hematopoietic system function",
                    "requirements": [
                        {
                            "requirement_type": "platelet count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "ul"
                            }
                        },
                        {
                            "requirement_type": "neutrophil count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "ul"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If the patient is female in fertile period, urine hCG test is negative",
                    "criterion": "urine hCG test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "If the patient is female in fertile period, ... she has no plan of pregnancy with 6 months after the termiation of whole treatment.",
                    "criterion": "pregnancy plan",
                    "requirements": [
                        {
                            "requirement_type": "plan",
                            "expected_value": "no plan of pregnancy within 6 months after treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "xiii. If the patient is male in fertile period, he agrees with contraception during treatment period and 6 months after the termination of whole treatment.",
            "criterions": [
                {
                    "exact_snippets": "patient is male in fertile period",
                    "criterion": "male fertility",
                    "requirements": [
                        {
                            "requirement_type": "fertility status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "he agrees with contraception during treatment period and 6 months after the termination of whole treatment",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "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": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 74 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 74 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 74,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* i. any suspicious distant metastasis ii. any other primary malignant lesion iii. Clinical stage T1or T2 and N0 iv. the sign of perforation or severe ischemia requiring ememgency operation v. the complication related to SEMS placement (severe bleeding and perforation after SEMS placement) vi. ASA 4 or more vii. ECOG 3 or more viii. colonic obstruction by benign stricture ix. pregnant woman or woman who is breastfeeding x. the paitents who already enrolled into other study or are taking medicine related to any clinical trial xi. the patients who are taking sorivudine xii. the patients who are taking Tegafur/gimeracil/oteracil xiii. the patietns who have a medical history of hypersensitivity reaction to 5-FU, oxaliplatin, leucovorin,or any medication including platinum.",
            "criterions": [
                {
                    "exact_snippets": "any suspicious distant metastasis",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "any other primary malignant lesion",
                    "criterion": "primary malignant lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical stage T1or T2 and N0",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "T2"
                            ]
                        },
                        {
                            "requirement_type": "nodal involvement",
                            "expected_value": "N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "the sign of perforation or severe ischemia requiring ememgency operation",
                    "criterion": "perforation or severe ischemia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "requiring emergency operation"
                        }
                    ]
                },
                {
                    "exact_snippets": "the complication related to SEMS placement (severe bleeding and perforation after SEMS placement)",
                    "criterion": "complication related to SEMS placement",
                    "requirements": [
                        {
                            "requirement_type": "complications",
                            "expected_value": [
                                "severe bleeding",
                                "perforation"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ASA 4 or more",
                    "criterion": "ASA score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG 3 or more",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "colonic obstruction by benign stricture",
                    "criterion": "colonic obstruction",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "benign stricture"
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnant woman or woman who is breastfeeding",
                    "criterion": "pregnancy or breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "pregnant",
                                "breastfeeding"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "the paitents who already enrolled into other study or are taking medicine related to any clinical trial",
                    "criterion": "enrollment in other study or taking medicine related to clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the patients who are taking sorivudine",
                    "criterion": "sorivudine intake",
                    "requirements": [
                        {
                            "requirement_type": "intake",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the patients who are taking Tegafur/gimeracil/oteracil",
                    "criterion": "Tegafur/gimeracil/oteracil intake",
                    "requirements": [
                        {
                            "requirement_type": "intake",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the patietns who have a medical history of hypersensitivity reaction to 5-FU, oxaliplatin, leucovorin,or any medication including platinum",
                    "criterion": "hypersensitivity reaction",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": [
                                "5-FU",
                                "oxaliplatin",
                                "leucovorin",
                                "any medication including platinum"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "xiv. Inappropriate function of vital organ (impaired renal function, elevated liver enzyme, and so on ) xv. Inappropriate function of hematopoietic system (platelet <100,000ul, neutrophil < 2,000ul) xvi. Genetic problem such as galactose intolerance, Lapp lactase deficiency, or glucose-galatose malabsorption)",
            "criterions": [
                {
                    "exact_snippets": "Inappropriate function of vital organ (impaired renal function",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "function",
                            "expected_value": "impaired"
                        }
                    ]
                },
                {
                    "exact_snippets": "Inappropriate function of vital organ ... elevated liver enzyme",
                    "criterion": "liver enzyme levels",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "elevated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Inappropriate function of hematopoietic system (platelet <100,000ul",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": "<",
                                "value": 100000,
                                "unit": "ul"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Inappropriate function of hematopoietic system ... neutrophil < 2,000ul",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": "<",
                                "value": 2000,
                                "unit": "ul"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Genetic problem such as galactose intolerance",
                    "criterion": "galactose intolerance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Genetic problem such as ... Lapp lactase deficiency",
                    "criterion": "Lapp lactase deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Genetic problem such as ... glucose-galatose malabsorption",
                    "criterion": "glucose-galactose malabsorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}