Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00006360|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Radiation Toxicity||Drug: radioprotection Radiation: radiation therapy||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||December 2016|
- Acute salivary gland toxicity
- Locoregional control
- Whole mouth saliva output relative to pre-radiotherapy measurements
- Acute mucositis and other acute and late toxicities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|