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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Oral Cavity Squamous Cell Carcinoma

Treatments: Drug: Cisplatin; Drug: Docetaxel; Radiation: IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02923258

2016HNRT004

Details and patient eligibility

About

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.

Enrollment: 224 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Experimental

Experimental group

Description:

Concurrent Chemoradiotherapy With Docetaxel and IMRT

Treatment:

Radiation: IMRT

Drug: Docetaxel

Control

Active Comparator group

Description:

Concurrent Chemoradiotherapy With Cisplatinum and IMRT

Treatment:

Radiation: IMRT

Drug: Cisplatin