Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT02923258
Eligibility Criteria:
Inclusion Criteria:
* 1.Histologically confirmed squamous cell carcinoma of the oral cavity 2. Gross total resection, with pathology demonstrating one or more of the following risk factors:
1. Histologic extracapsular nodal extension
2. Histologic involvement of ≥ 2 regional lymph nodes
3. Invasive cancer is seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual 3. No evidence of distant metastases 4. No synchronous or concurrent head and neck primary tumors 5. ECOG 0-1 6. Adequate organ function including the following:
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1. Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
2. Platelets count \>= 100 \* 10\^9/l
3. Hemoglobin \>= 10 g/dl
4. AST and ALT \<= 2.5 times institutional upper limit of normal (ULN)
5. Total bilirubin \<= 1.5 times institutional ULN
6. Creatinine clearance \>= 50 ml/min
7. Serum creatine \<= 1 times ULN 7.Signed written informed consent
Exclusion Criteria:
* 1\. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5.Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02923258
Study Brief:
Protocol Section:
NCT02923258