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

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 site in 1 country224 target enrollmentApril 21, 2018

ConditionsOral Cavity Squamous Cell Carcinoma

InterventionsCisplatin Docetaxel IMRT

DrugsDocetaxel Cisplatin

Overview

Phase: Phase 2
Intervention: Cisplatin
Conditions: Oral Cavity Squamous Cell Carcinoma
Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Enrollment: 224
Locations: 1
Primary Endpoint: Disease-free survival (DFS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 21, 2018

End Date

April 30, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Responsible Party

Principal Investigator

Guopei Zhu

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Eligibility Criteria

Inclusion Criteria

•1.Histologically confirmed squamous cell carcinoma of the oral cavity
•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
•No evidence of distant metastases
•No synchronous or concurrent head and neck primary tumors
•Adequate organ function including the following:
•Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
•Platelets count \>= 100 \* 10\^9/l

Exclusion Criteria

•Evidence of distant metastasis
•Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
•Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
•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