Oral Cavity Squamous Cell Carcinoma
Conditions
Keywords
oral cavity squamous cell carcinoma, concurrent chemotherapy, High-Risk
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.
Interventions
DRUGDocetaxel
20mg/m2/w
DRUGCisplatin
100mg/m2/q3w
RADIATIONIMRT
a total dose of 60Gy in 30fractions over 6 weeks
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
China
Outcome results
None listed