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

Oral Cavity Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923258
• Other study ID #: 2016HNRT004
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 21, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2024
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: April 30, 2023
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Mouth Neoplasms
• Oral Cavity Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Docetaxel
20mg/m2/w
• Cisplatin
100mg/m2/q3w

Radiation:
• IMRT
a total dose of 60Gy in 30fractions over 6 weeks

Locations

Country	Name	City	State
China	Shanghai ninth people's hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

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