Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT00011999
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy following surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer.
- Detailed Description
OBJECTIVES:
* Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck.
* Determine the disease-free and overall survival of patients treated with this regimen.
* Determine the acute and chronic toxicity of this regimen in these patients.
* Determine the patterns of failure in patients treated with this regimen.
OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5 weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Surgery, chemotherapy and radiation therapy cisplatin Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer. Surgery, chemotherapy and radiation therapy conventional surgery Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer. Surgery, chemotherapy and radiation therapy radiation therapy Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer. Surgery, chemotherapy and radiation therapy paclitaxel Early post-operative paclitaxel followed by paclitaxel and cisplatin concurrent with radiation therapy for resected head and neck cancer.
- Primary Outcome Measures
Name Time Method Patient tolerance of the treatment regimen From registration to end of treatment
- Secondary Outcome Measures
Name Time Method Frequency of grade 5 and acute non-hematologic grade 4 toxicity From start of induction chemotherapy to 90 days after start of radiation therapy Frequency of other acute and late toxicity From start of induction chemotherapy to last follow-up Local-regional control From registration to date of failure (local or regional progression) or death or last follow-up. Analysis occurs after patients have been followed for at least 2 years. Disease-free survival From registration to date of failure (local, regional, or distant progression, or second primary or death) or last follow-up. Analysis occurs after patients have been followed for at least 2 years. Overall survival From registration to date of death or last follow-up. Analysis occurs after patients have been followed for at least 2 years.
Trial Locations
- Locations (234)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
DCH Cancer Treatment Center
🇺🇸Tuscaloosa, Alabama, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Mount Diablo Medical Center
🇺🇸Concord, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Saint Agnes Cancer Center
🇺🇸Fresno, California, United States
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