Clinical trial NCT02923258: Postoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Oral Cavity Squamous Cell Carcinoma
Keywords: oral cavity squamous cell carcinoma
concurrent chemotherapy
High-Risk
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Locoregional failure-free survival (LRFS)
timeFrame: 2 years
measure: distant metastasis free survival (DMFS)
timeFrame: 2 years
measure: Adverse Events (AE)
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ninth people's hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Guopei Zhu
role: STUDY_CHAIR
References: