S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00054054
- Lead Sponsor
- SWOG Cancer Research Network
- 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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer.
- Detailed Description
OBJECTIVES:
* Determine the overall survival of patients with stage III or IV squamous cell head and neck cancer treated with docetaxel, cisplatin, and fluorouracil followed by accelerated fractionation/concomitant boost radiotherapy and cisplatin.
* Determine the unconfirmed complete response rate in these patients after treatment with induction chemotherapy.
* Determine the overall complete response rate (confirmed and unconfirmed) in patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
OUTLINE:
* Induction Chemotherapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity.
* Chemoradiotherapy: Beginning within 3-4 weeks after administration of the second course of induction chemotherapy, patients receive accelerated fractionation radiotherapy once daily, 5 days per week, for 6 weeks with concomitant boost radiotherapy once daily, 5 days a week, for the last 2.5 weeks of radiotherapy. Patients also receive concurrent cisplatin IV over 30-60 minutes on days 1 and 22.
Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (95)
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
California Cancer Center
🇺🇸Fresno, California, United States
Veterans Affairs Medical Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
🇺🇸Shreveport, Louisiana, United States
CCOP - Beaumont
🇺🇸Royal Oak, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
🇺🇸Jackson, Mississippi, United States
Providence Cancer Institute at Providence Hospital
🇺🇸Southfield, Michigan, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Cancer Research Center at Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Veterans Affairs Medical Center - Houston
🇺🇸Houston, Texas, United States
Veterans Affairs Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Puget Sound Oncology Consortium
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
🇺🇸Phoenix, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
🇺🇸Martinez, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
MBCCOP - Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Charleston
🇺🇸Charleston, South Carolina, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
Veterans Affairs Medical Center - Amarillo
🇺🇸Amarillo, Texas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
David Grant Medical Center
🇺🇸Travis Air Force Base, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
🇺🇸Orange, California, United States
CCOP - Santa Rosa Memorial Hospital
🇺🇸Santa Rosa, California, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
🇺🇸Hines, Illinois, United States
MBCCOP - University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
🇺🇸New Orleans, Louisiana, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
St. Louis University Hospital Cancer Center
🇺🇸Saint Louis, Missouri, United States
Veterans Affairs Medical Center - East Orange
🇺🇸East Orange, New Jersey, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
🇺🇸Albuquerque, New Mexico, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Veterans Affairs Medical Center - Salisbury
🇺🇸Salisbury, North Carolina, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Veterans Affairs Medical Center - Temple
🇺🇸Temple, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Veterans Affairs Medical Center - Tampa (Haley)
🇺🇸Tampa, Florida, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States