{
    "info": {
        "nct_id": "NCT03196843",
        "official_title": "Radiotherapy Combine With Raltitrexed Versus Radiotherapy Alone in Older Patients With Head and Neck Squamous Cell Carcinoma: a Prospective Randomized Controlled Trial",
        "inclusion_criteria": "1. Before participate in the study, patients must understand the treatment plan and willing to participate in the study. Patients must have signed an approved informed consent.\n2. Histopathologic confirmed squamous cell carcinoma of head and neck ,including oral cavity, oropharynx, larynx, or hypopharynx.\n3. Ages≥65 years,Not limited to gender.\n4. ECOG performance status ≤2.\n5. Patients with surgical contraindication or reject to surgery.\n6. Postoperative TNM(primary tumor,regional nodes,metastasis) staging III~IV, positive surgical margin.\n7. without evidence of distant metastases.\n8. No contraindication to chemoradiotherapy.\n9. Life expectancy > 3 months.\n10. Available Organ function: white blood cell≥3.5×109/L, Neutrophils ≥1.5×109/L, Hemoglobin ≥80g/L, Blood platelet>100×109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤ 2.5 upper limit of normal(ULN); Total bilirubin (TBIL) <1.5 ULN;serum creatinine≤1.5 ULN; creatinine clearance of ≥ 50ml/min\nHealthy volunteers allowed\nMust have minimum age of 65 Years",
        "exclusion_criteria": "1. Patients with a history of any other malignancy.\n2. Concomitant treatment with any other anticancer therapy.\n3. Patient have contraindication to chemotherapy(eg.uncontrolled coronarism and heart failure; History of myocardial infarction within the past 6 months, Chronic obstructive pulmonary, uncontrolled epileptic attack and other disease that investigator consider it unsuitable for the chemotherapy)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Before participate in the study, patients must understand the treatment plan and willing to participate in the study. Patients must have signed an approved informed consent.",
            "criterions": [
                {
                    "exact_snippets": [
                        "understand the treatment plan"
                    ],
                    "criterion": "treatment plan",
                    "requirement_type": "understanding",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "willing to participate in the study"
                    ],
                    "criterion": "study participation",
                    "requirement_type": "willingness",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "signed an approved informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "signed",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Histopathologic confirmed squamous cell carcinoma of head and neck ,including oral cavity, oropharynx, larynx, or hypopharynx.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Histopathologic confirmed squamous cell carcinoma"
                    ],
                    "criterion": "squamous cell carcinoma",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "head and neck"
                    ],
                    "criterion": "cancer location",
                    "requirement_type": "presence",
                    "expected_value": [
                        "head",
                        "neck"
                    ]
                },
                {
                    "exact_snippets": [
                        "oral cavity"
                    ],
                    "criterion": "cancer location",
                    "requirement_type": "presence",
                    "expected_value": "oral cavity"
                },
                {
                    "exact_snippets": [
                        "oropharynx"
                    ],
                    "criterion": "cancer location",
                    "requirement_type": "presence",
                    "expected_value": "oropharynx"
                },
                {
                    "exact_snippets": [
                        "larynx"
                    ],
                    "criterion": "cancer location",
                    "requirement_type": "presence",
                    "expected_value": "larynx"
                },
                {
                    "exact_snippets": [
                        "hypopharynx"
                    ],
                    "criterion": "cancer location",
                    "requirement_type": "presence",
                    "expected_value": "hypopharynx"
                }
            ]
        },
        {
            "line": "3. Ages≥65 years,Not limited to gender.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Ages≥65 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 65
                    }
                },
                {
                    "exact_snippets": [
                        "Not limited to gender"
                    ],
                    "criterion": "gender",
                    "requirement_type": "limitation",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "4. ECOG performance status ≤2.",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG performance status ≤2"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "5. Patients with surgical contraindication or reject to surgery.",
            "criterions": [
                {
                    "exact_snippets": [
                        "surgical contraindication"
                    ],
                    "criterion": "surgical contraindication",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "reject to surgery"
                    ],
                    "criterion": "surgery",
                    "requirement_type": "willingness",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "6. Postoperative TNM(primary tumor,regional nodes,metastasis) staging III~IV, positive surgical margin.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Postoperative TNM(primary tumor,regional nodes,metastasis) staging III~IV"
                    ],
                    "criterion": "TNM staging",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3
                            },
                            {
                                "operator": "<=",
                                "value": 4
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "positive surgical margin"
                    ],
                    "criterion": "surgical margin",
                    "requirement_type": "status",
                    "expected_value": "positive"
                }
            ]
        },
        {
            "line": "7. without evidence of distant metastases.",
            "criterions": [
                {
                    "exact_snippets": [
                        "without evidence of distant metastases"
                    ],
                    "criterion": "distant metastases",
                    "requirement_type": "evidence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "8. No contraindication to chemoradiotherapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "No contraindication to chemoradiotherapy"
                    ],
                    "criterion": "contraindication to chemoradiotherapy",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "9. Life expectancy > 3 months.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life expectancy > 3 months"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "10. Available Organ function: white blood cell≥3.5×109/L, Neutrophils ≥1.5×109/L, Hemoglobin ≥80g/L, Blood platelet>100×109/L; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤ 2.5 upper limit of normal(ULN); Total bilirubin (TBIL) <1.5 ULN;serum creatinine≤1.5 ULN; creatinine clearance of ≥ 50ml/min",
            "criterions": [
                {
                    "exact_snippets": [
                        "white blood cell≥3.5×109/L"
                    ],
                    "criterion": "white blood cell",
                    "requirement_type": "count",
                    "expected_value": {
                        "operator": ">=",
                        "value": 3.5
                    }
                },
                {
                    "exact_snippets": [
                        "Neutrophils ≥1.5×109/L"
                    ],
                    "criterion": "neutrophils",
                    "requirement_type": "count",
                    "expected_value": {
                        "operator": ">=",
                        "value": 1.5
                    }
                },
                {
                    "exact_snippets": [
                        "Hemoglobin ≥80g/L"
                    ],
                    "criterion": "hemoglobin",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": ">=",
                        "value": 80
                    }
                },
                {
                    "exact_snippets": [
                        "Blood platelet>100×109/L"
                    ],
                    "criterion": "blood platelet",
                    "requirement_type": "count",
                    "expected_value": {
                        "operator": ">",
                        "value": 100
                    }
                },
                {
                    "exact_snippets": [
                        "Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤ 2.5 upper limit of normal(ULN)"
                    ],
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<=",
                        "value": 2.5
                    }
                },
                {
                    "exact_snippets": [
                        "Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤ 2.5 upper limit of normal(ULN)"
                    ],
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<=",
                        "value": 2.5
                    }
                },
                {
                    "exact_snippets": [
                        "Total bilirubin (TBIL) <1.5 ULN"
                    ],
                    "criterion": "total bilirubin (TBIL)",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<",
                        "value": 1.5
                    }
                },
                {
                    "exact_snippets": [
                        "serum creatinine≤1.5 ULN"
                    ],
                    "criterion": "serum creatinine",
                    "requirement_type": "level",
                    "expected_value": {
                        "operator": "<=",
                        "value": 1.5
                    }
                },
                {
                    "exact_snippets": [
                        "creatinine clearance of ≥ 50ml/min"
                    ],
                    "criterion": "creatinine clearance",
                    "requirement_type": "rate",
                    "expected_value": {
                        "operator": ">=",
                        "value": 50
                    }
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 65 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 65
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients with a history of any other malignancy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "history of any other malignancy"
                    ],
                    "criterion": "other malignancy",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Concomitant treatment with any other anticancer therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Concomitant treatment with any other anticancer therapy"
                    ],
                    "criterion": "anticancer therapy",
                    "requirement_type": "concomitant treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. Patient have contraindication to chemotherapy(eg.uncontrolled coronarism and heart failure; History of myocardial infarction within the past 6 months, Chronic obstructive pulmonary, uncontrolled epileptic attack and other disease that investigator consider it unsuitable for the chemotherapy)",
            "criterions": [
                {
                    "exact_snippets": [
                        "contraindication to chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "contraindication",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "uncontrolled coronarism"
                    ],
                    "criterion": "coronarism",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "heart failure"
                    ],
                    "criterion": "heart failure",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "History of myocardial infarction within the past 6 months"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "history",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Chronic obstructive pulmonary"
                    ],
                    "criterion": "chronic obstructive pulmonary disease",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "uncontrolled epileptic attack"
                    ],
                    "criterion": "epileptic attack",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "other disease that investigator consider it unsuitable for the chemotherapy"
                    ],
                    "criterion": "other disease",
                    "requirement_type": "suitability for chemotherapy",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}