Postoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer

Study Overview
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Brief Summary
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This is a randomized,controled, phase II, open label study of postoperative concurrent chemoradiotherapy with Docetaxel versus Cisplatin for high-risk squamous cell carcinoma of the oral cavity cancer.The primary purpose of this study is to evaluate the efficacy of concurrent chemoradiotherapy with docetaxel in OCC patients.

Official Title
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Postoperative Radiation and Concurrent Chemotherapy With Weekly Docetaxel Versus Cisplatin in Patients With High-risk Oral Cavity Cancer: a Randomized Phase II Clinical Trial

Conditions
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Oral Cavity Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Cisplatin
* Radiation: IMRT


Participation Criteria
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Eligibility Criteria
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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: Histologic extracapsular nodal extension Histologic involvement of ≥ 2 regional lymph nodes 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: Absolute neutrophil count (ANC) >= 1.5 * 10^9/l Platelets count >= 100 * 10^9/l Hemoglobin >= 10 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >= 50 ml/min 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Concurrent Chemoradiotherapy With Docetaxel and IMRT | Drug: Docetaxel<br>* 20mg/m2/w<br>Radiation: IMRT<br>* a total dose of 60Gy in 30fractions over 6 weeks<br>|
| Active Comparator: Control<br>Concurrent Chemoradiotherapy With Cisplatinum and IMRT | Drug: Cisplatin<br>* 100mg/m2/q3w<br>Radiation: IMRT<br>* a total dose of 60Gy in 30fractions over 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity profiles, graded according to the NCI CTCAE version 5.0 |  | up to 6-7 weeks | 
| Late toxicity profiles, graded according to the NCI CTCAE version 4.0 |  | up to 2 years | 
| overall survival rate |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral cavity squamous cell carcinoma, concurrent chemotherapy, High-Risk