Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Salivary Gland Carcinomas of Head and Neck, A Non-Randomized, Phase II Trial
Overview
- Phase
- Phase 2
- Intervention
- Nedaplatin
- Conditions
- Salivary Gland Tumors
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Disease-free survival
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.
Investigators
Guopei Zhu
M.D.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Eligibility Criteria
Inclusion Criteria
- •Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
- •Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
- •Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
- •No evidence of distant metastases
- •No synchronous or concurrent head and neck primary tumors
- •Karnofsky score over 60
- •Adequate organ function including the following:
- •Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l
- •Platelets count \>= 100 \* 10\^9/l
- •Hemoglobin \>= 10 g/dl
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
- •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
Arms & Interventions
ACC
Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Intervention: Nedaplatin
ACC
Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Intervention: Docetaxel
ACC
Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Intervention: Intensity-modulated radiotherapy
Non-ACC
Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Intervention: Nedaplatin
Non-ACC
Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Intervention: Docetaxel
Non-ACC
Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and Nedaplatin
Intervention: Intensity-modulated radiotherapy
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: 2 years
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Secondary Outcomes
- Acute toxicity profiles, graded according to the NCI CTCAE version 3.0(up to 6 weeks)
- Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Overall survival rate(2 years)
- Late toxicity profiles, graded according to the NCI CTCAE version 3.0(up to 2 years)