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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006360 |
Purpose
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 | Intervention | Phase |
|
Cancer-Related Problem/Condition Head and Neck Cancer |
Procedure: radiation therapy Procedure: radioprotection |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Head and Neck Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer |
| Study Start Date: | February 2001 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven stage II or III (T1-T2, N0-N1) squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or palate)
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| 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 | |||||
| Community Regional Cancer Center at Community Medical Center | |||||
| Toms River, New Jersey, United States, 08755 | |||||
| Monmouth Medical Center | |||||
| Long Branch, New Jersey, United States, 07740-6395 | |||||
| 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 | |||||
| LDS Hospital | |||||
| 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 | |||||
| All Saints Cancer Center at All Saints Healthcare | |||||
| Racine, Wisconsin, United States, 53405 | |||||
| CCOP - Marshfield Clinic Research Foundation | |||||
| Marshfield, Wisconsin, United States, 54449 | |||||
| Medical College of Wisconsin Cancer Center | |||||
| Milwaukee, Wisconsin, United States, 53226 | |||||
| Canada, Alberta | |||||
| Stollery Children's Hospital at University of Alberta Hospital | |||||
| Edmonton, Alberta, Canada, T6G 2R7 | |||||
| Canada, Quebec | |||||
| Centre Hospitalier de l'Universite de Montreal | |||||
| Montreal, Quebec, Canada, H2L 4MI | |||||
| McGill Cancer Centre at McGill University | |||||
| Montreal, Quebec, Canada, H2W 1S6 | |||||
| Radiation Therapy Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Avraham Eisbruch, MD | University of Michigan Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
|
Eisbruch A, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT for oropharyngeal cancer (RTOG 00-22): early results. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-79, S46-7, 2006.
  |
| Study ID Numbers: | CDR0000068231, RTOG-0022, RTOG-H-0022, RTOG-DEV-1065 |
| First Received: | October 4, 2000 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006360 |
| Health Authority: | United States: Federal Government |
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