S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT00084435
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in 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. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV head and neck cancer.
- Detailed Description
OBJECTIVES:
* Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin.
* Determine the toxicity of this regimen in these patients.
* Categorize the site(s) of disease relapse in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5 months.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description chemoRT after surgery radiation therapy chemoRT with cisplatin and docetaxel after surgery chemoRT after surgery cisplatin chemoRT with cisplatin and docetaxel after surgery chemoRT after surgery docetaxel chemoRT with cisplatin and docetaxel after surgery
- Primary Outcome Measures
Name Time Method Disease progression Disease-free survival Symptomatic deterioration Toxicity
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (29)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸Shreveport, Louisiana, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Scroll for more (19 remaining)USC/Norris Comprehensive Cancer Center and Hospital🇺🇸Los Angeles, California, United States