Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer.
|Head and Neck Cancer Radiation Toxicity||Drug: radioprotection Radiation: radiation therapy||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer|
- Acute salivary gland toxicity
- Locoregional control
- Whole mouth saliva output relative to pre-radiotherapy measurements
- Acute mucositis and other acute and late toxicities
|Study Start Date:||February 2001|
|Study Completion Date:||December 2016|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
- Assess target coverage and major salivary gland sparing in patients with stage II or III oropharyngeal cancer treated with intensity-modulated radiotherapy.
- Determine the nature and prevalence of acute and late side effects of this treatment in these patients.
- Determine the rate and pattern of locoregional tumor recurrence in these patients after this treatment.
OUTLINE: This is a multicenter study.
Patients receive 3-D conformal radiotherapy and/or intensity-modulated radiotherapy daily 5 days a week for 6 weeks, in an effort to spare major salivary glands.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 57-64 patients will be accrued for this study over 27 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006360
|United States, Arizona|
|Foundation for Cancer Research and Education|
|Phoenix, Arizona, United States, 85013|
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|United States, Florida|
|University of Florida Shands Cancer Center|
|Gainesville, Florida, United States, 32610-0385|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0010|
|United States, Missouri|
|CCOP - Kansas City|
|Kansas City, Missouri, United States, 64131|
|United States, New Jersey|
|Monmouth Medical Center|
|Long Branch, New Jersey, United States, 07740-6395|
|Community Regional Cancer Center at Community Medical Center|
|Toms River, New Jersey, United States, 08755|
|United States, Pennsylvania|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|United States, Utah|
|Dixie Regional Medical Center|
|Saint George, Utah, United States, 84770|
|Salt Lake City, Utah, United States, 84143|
|United States, Vermont|
|Community Cancer Center at Rutland Regional Medical Center|
|Rutland, Vermont, United States, 05701|
|United States, Wisconsin|
|CCOP - Marshfield Clinic Research Foundation|
|Marshfield, Wisconsin, United States, 54449|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226|
|All Saints Cancer Center at All Saints Healthcare|
|Racine, Wisconsin, United States, 53405|
|Stollery Children's Hospital at University of Alberta Hospital|
|Edmonton, Alberta, Canada, T6G 2R7|
|Centre Hospitalier de l'Universite de Montreal|
|Montreal, Quebec, Canada, H2L 4MI|
|McGill Cancer Centre at McGill University|
|Montreal, Quebec, Canada, H2W 1S6|
|Study Chair:||Avraham Eisbruch, MD||University of Michigan Cancer Center|