{
    "info": {
        "nct_id": "NCT03017053",
        "official_title": "The Optimal Neck Treatments Strategy of Early Oral Cancer Based on Adverse Pathological Factor",
        "inclusion_criteria": "1. Ability to understand and the willingness to sign a written informed consent document\n2. Age≥ 18 and≤ 75 years\n3. Clinical/ Histological/ cytological/ Imaging examination proven Oral/Oropharynx Squamous-cell carcinoma (Tongue, buccal mucosa, mouth floor, hard palate, Molar area), the depth of invasion > 4mm in preoperative assessment\n4. In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving surgical resection\n5. KPS≥ 70\n6. Normal bone marrow reserve function and normal liver, kidney function\n7. Expected survival period≥ 6 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Inability to provide an informed consent\n2. Evidence of oral distant metastasis or other malignancies\n3. The patient has received prior surgery for primary tumor or lymph node ( except for biopsy )\n4. Prior radiotherapy for primary tumor\n5. The patient has previously received anti-tumor biological targeted therapy\n6. The patient has received chemotherapy or immunotherapy for primary tumors\n7. Prior malignancy within the previous 5 years (except for cured skin basal cell carcinoma or cervical carcinoma in situ)\n8. With 3-4 grad Allergy to any drug in the treatment\n9. Peripheral neuropathy> 1 grade\n10. Any unstable systematic disease (including active infection, uncontrolled high blood pressure, unstable angina, onset of angina within the last 3 months, congestive heart failure, myocardial infarction within the previous 12 months, severe arrhythmia needing drug treatment, liver, kidney or metabolic disease)\n11. HIV positive\n12. Chronic diseases requiring immune agents or hormone therapy\n13. Pregnant or lactating women\n14. Drug/alcohol abuse, psychological or spiritual illness that may interfere compliance to the study\n15. Patients with epilepsy requiring medications (such as steroids or antiepileptic drugs)\n16. The patient has participated in other experimental therapy studies within 30 days\n17. Researchers believe that the situation is unsuitable for participation in the group",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Ability to understand and the willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": [
                        "Ability to understand"
                    ],
                    "criterion": "understanding",
                    "requirement_type": "ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "willingness to sign a written informed consent document"
                    ],
                    "criterion": "informed consent document",
                    "requirement_type": "willingness to sign",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Age≥ 18 and≤ 75 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age≥ 18",
                        "≤ 75 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            },
                            {
                                "operator": "<=",
                                "value": 75
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "3. Clinical/ Histological/ cytological/ Imaging examination proven Oral/Oropharynx Squamous-cell carcinoma (Tongue, buccal mucosa, mouth floor, hard palate, Molar area), the depth of invasion > 4mm in preoperative assessment",
            "criterions": [
                {
                    "exact_snippets": [
                        "Clinical/ Histological/ cytological/ Imaging examination proven Oral/Oropharynx Squamous-cell carcinoma"
                    ],
                    "criterion": "Oral/Oropharynx Squamous-cell carcinoma",
                    "requirement_type": "diagnosis method",
                    "expected_value": [
                        "Clinical",
                        "Histological",
                        "cytological",
                        "Imaging"
                    ]
                },
                {
                    "exact_snippets": [
                        "Tongue, buccal mucosa, mouth floor, hard palate, Molar area"
                    ],
                    "criterion": "Oral/Oropharynx Squamous-cell carcinoma location",
                    "requirement_type": "location",
                    "expected_value": [
                        "Tongue",
                        "buccal mucosa",
                        "mouth floor",
                        "hard palate",
                        "Molar area"
                    ]
                },
                {
                    "exact_snippets": [
                        "depth of invasion > 4mm"
                    ],
                    "criterion": "depth of invasion",
                    "requirement_type": "measurement",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "4. In line with clinical stage I / II stage (T1-2 N0 M0; AJCC 2010) and receiving surgical resection",
            "criterions": [
                {
                    "exact_snippets": [
                        "clinical stage I / II stage"
                    ],
                    "criterion": "clinical stage",
                    "requirement_type": "stage",
                    "expected_value": [
                        "I",
                        "II"
                    ]
                },
                {
                    "exact_snippets": [
                        "T1-2"
                    ],
                    "criterion": "tumor size",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1
                            },
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "N0"
                    ],
                    "criterion": "lymph node involvement",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "M0"
                    ],
                    "criterion": "distant metastasis",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "receiving surgical resection"
                    ],
                    "criterion": "surgical resection",
                    "requirement_type": "treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "5. KPS≥ 70",
            "criterions": [
                {
                    "exact_snippets": [
                        "KPS",
                        "≥ 70"
                    ],
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirement_type": "minimum value",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 70
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "6. Normal bone marrow reserve function and normal liver, kidney function",
            "criterions": [
                {
                    "exact_snippets": [
                        "Normal bone marrow reserve function"
                    ],
                    "criterion": "bone marrow reserve",
                    "requirement_type": "function",
                    "expected_value": "normal"
                },
                {
                    "exact_snippets": [
                        "normal liver",
                        "function"
                    ],
                    "criterion": "liver",
                    "requirement_type": "function",
                    "expected_value": "normal"
                },
                {
                    "exact_snippets": [
                        "normal",
                        "kidney function"
                    ],
                    "criterion": "kidney",
                    "requirement_type": "function",
                    "expected_value": "normal"
                }
            ]
        },
        {
            "line": "7. Expected survival period≥ 6 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "Expected survival period",
                        "≥ 6 months"
                    ],
                    "criterion": "survival period",
                    "requirement_type": "expected duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 75 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 75
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Inability to provide an informed consent",
            "criterions": [
                {
                    "exact_snippets": [
                        "Inability to provide an informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "ability to provide",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "2. Evidence of oral distant metastasis or other malignancies",
            "criterions": [
                {
                    "exact_snippets": [
                        "Evidence of oral distant metastasis"
                    ],
                    "criterion": "oral distant metastasis",
                    "requirement_type": "evidence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "other malignancies"
                    ],
                    "criterion": "other malignancies",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. The patient has received prior surgery for primary tumor or lymph node ( except for biopsy )",
            "criterions": [
                {
                    "exact_snippets": [
                        "received prior surgery for primary tumor"
                    ],
                    "criterion": "primary tumor",
                    "requirement_type": "prior surgery",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "received prior surgery for",
                        "lymph node"
                    ],
                    "criterion": "lymph node",
                    "requirement_type": "prior surgery",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "except for biopsy"
                    ],
                    "criterion": "biopsy",
                    "requirement_type": "prior surgery",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "4. Prior radiotherapy for primary tumor",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior radiotherapy for primary tumor"
                    ],
                    "criterion": "radiotherapy",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "primary tumor"
                    ],
                    "criterion": "primary tumor",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "5. The patient has previously received anti-tumor biological targeted therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "previously received anti-tumor biological targeted therapy"
                    ],
                    "criterion": "anti-tumor biological targeted therapy",
                    "requirement_type": "previous administration",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "6. The patient has received chemotherapy or immunotherapy for primary tumors",
            "criterions": [
                {
                    "exact_snippets": [
                        "received chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "received",
                        "immunotherapy"
                    ],
                    "criterion": "immunotherapy",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "primary tumors"
                    ],
                    "criterion": "primary tumors",
                    "requirement_type": "treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "7. Prior malignancy within the previous 5 years (except for cured skin basal cell carcinoma or cervical carcinoma in situ)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior malignancy within the previous 5 years"
                    ],
                    "criterion": "prior malignancy",
                    "requirement_type": "time since occurrence",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "cured skin basal cell carcinoma"
                    ],
                    "criterion": "skin basal cell carcinoma",
                    "requirement_type": "cured",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "cervical carcinoma in situ"
                    ],
                    "criterion": "cervical carcinoma in situ",
                    "requirement_type": "cured",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "8. With 3-4 grad Allergy to any drug in the treatment",
            "criterions": [
                {
                    "exact_snippets": [
                        "3-4 grad Allergy to any drug in the treatment"
                    ],
                    "criterion": "allergy to any drug in the treatment",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3
                            },
                            {
                                "operator": "<=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "9. Peripheral neuropathy> 1 grade",
            "criterions": [
                {
                    "exact_snippets": [
                        "Peripheral neuropathy"
                    ],
                    "criterion": "peripheral neuropathy",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "10. Any unstable systematic disease (including active infection, uncontrolled high blood pressure, unstable angina, onset of angina within the last 3 months, congestive heart failure, myocardial infarction within the previous 12 months, severe arrhythmia needing drug treatment, liver, kidney or metabolic disease)",
            "criterions": [
                {
                    "exact_snippets": [
                        "unstable systematic disease"
                    ],
                    "criterion": "systematic disease",
                    "requirement_type": "stability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "active infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "uncontrolled high blood pressure"
                    ],
                    "criterion": "high blood pressure",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "unstable angina"
                    ],
                    "criterion": "angina",
                    "requirement_type": "stability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "onset of angina within the last 3 months"
                    ],
                    "criterion": "angina onset",
                    "requirement_type": "time frame",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 3
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "congestive heart failure"
                    ],
                    "criterion": "congestive heart failure",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "myocardial infarction within the previous 12 months"
                    ],
                    "criterion": "myocardial infarction",
                    "requirement_type": "time frame",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 12
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "severe arrhythmia needing drug treatment"
                    ],
                    "criterion": "arrhythmia",
                    "requirement_type": "severity and treatment",
                    "expected_value": "severe, drug treatment needed"
                },
                {
                    "exact_snippets": [
                        "liver, kidney or metabolic disease"
                    ],
                    "criterion": "liver, kidney or metabolic disease",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "11. HIV positive",
            "criterions": [
                {
                    "exact_snippets": [
                        "HIV positive"
                    ],
                    "criterion": "HIV",
                    "requirement_type": "status",
                    "expected_value": "positive"
                }
            ]
        },
        {
            "line": "12. Chronic diseases requiring immune agents or hormone therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Chronic diseases"
                    ],
                    "criterion": "chronic diseases",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "requiring immune agents"
                    ],
                    "criterion": "immune agents",
                    "requirement_type": "requirement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "requiring",
                        "hormone therapy"
                    ],
                    "criterion": "hormone therapy",
                    "requirement_type": "requirement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "13. Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": [
                        "Pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "14. Drug/alcohol abuse, psychological or spiritual illness that may interfere compliance to the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "Drug/alcohol abuse"
                    ],
                    "criterion": "drug/alcohol abuse",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "psychological or spiritual illness"
                    ],
                    "criterion": "psychological or spiritual illness",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "15. Patients with epilepsy requiring medications (such as steroids or antiepileptic drugs)",
            "criterions": [
                {
                    "exact_snippets": [
                        "epilepsy"
                    ],
                    "criterion": "epilepsy",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "requiring medications"
                    ],
                    "criterion": "medications",
                    "requirement_type": "necessity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "such as steroids",
                        "antiepileptic drugs"
                    ],
                    "criterion": "medications",
                    "requirement_type": "type",
                    "expected_value": [
                        "steroids",
                        "antiepileptic drugs"
                    ]
                }
            ]
        },
        {
            "line": "16. The patient has participated in other experimental therapy studies within 30 days",
            "criterions": [
                {
                    "exact_snippets": [
                        "participated in other experimental therapy studies within 30 days"
                    ],
                    "criterion": "participation in other experimental therapy studies",
                    "requirement_type": "time since last participation",
                    "expected_value": {
                        "operator": "<=",
                        "value": 30
                    }
                }
            ]
        },
        {
            "line": "17. Researchers believe that the situation is unsuitable for participation in the group",
            "criterions": [
                {
                    "exact_snippets": [
                        "situation is unsuitable for participation"
                    ],
                    "criterion": "situation",
                    "requirement_type": "suitability",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}