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Conformal and Intensity Modulated Irradiation for 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.
OBJECTIVES: * 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.
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Foundation for Cancer Research and Education
Phoenix, Arizona, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Community Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Start Date
February 1, 2001
Primary Completion Date
November 1, 2005
Completion Date
December 1, 2016
Last Updated
October 22, 2020
radioprotection
DRUG
radiation therapy
RADIATION
Lead Sponsor
Radiation Therapy Oncology Group
Collaborators
NCT04585750
NCT06636188
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07457346