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

Phase 2

Completed

• Conditions: Oral Cavity Squamous Cell Carcinoma
• Interventions: Drug: Docetaxel; Drug: Cisplatin; Radiation: IMRT

• Registration Number: NCT02923258
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Study Start: 2018-04-21
• Primary Completion: 2022-02-28
• Study Completion: 2023-04-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	IMRT	Concurrent Chemoradiotherapy With Docetaxel and IMRT
Control	IMRT	Concurrent Chemoradiotherapy With Cisplatinum and IMRT
Experimental	Docetaxel	Concurrent Chemoradiotherapy With Docetaxel and IMRT
Control	Cisplatin	Concurrent Chemoradiotherapy With Cisplatinum and IMRT

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	2 years

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AE)	3 months	AEs were summarized and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Overall Survival (OS)	2 years	the time in months between the date of random assignment and the date of death from any cause
Locoregional failure-free survival (LRFS)	2 years	the time in months between random assignment and the date of first locoregional recurrence or death from any cause, whichever occurred first
distant metastasis free survival (DMFS)	2 years	the time from random assignment to the first distant metastasis or death from any cause

Trial Locations

Locations (1)

Shanghai ninth people's hospital; 🇨🇳 Shanghai, Shanghai, China