Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
NCT ID: NCT00006360
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
INTERVENTIONAL
2001-02-28
2016-12-31
Brief Summary
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PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients who have stage II or stage III oropharyngeal cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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radioprotection
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Greater than 1 cm in one dimension or with necrotic regions if by CT or MRI scan
* Surgery of the primary tumor or lymph nodes limited to incisional or excisional biopsies
* No distant metastases
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No active untreated infection
* No other malignancy within the past 5 years except nonmelanoma skin cancer or a carcinoma not of head or neck origin
* No concurrent major medical or psychiatric illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* More than 3 months since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior head or neck radiotherapy
Surgery:
* See Disease Characteristics
Other:
* No other concurrent treatment for head and neck cancer
* No prophylactic amifostine or pilocarpine
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Avraham Eisbruch, MD
Role: STUDY_CHAIR
University of Michigan Rogel Cancer Center
Locations
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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
Dixie Regional Medical Center
St. George, Utah, United States
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States
Stollery Children's Hospital at University of Alberta Hospital
Edmonton, Alberta, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
Countries
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References
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Ploquin N, Lau H, Dunscombe P. Intensity modulated and three-dimensional conformal radiation therapy plans for oropharyngeal cancer: a comparison of their sensitivity to set-up errors and uncertainties. Curr Oncol. 2006 Apr;13(2):61-6. doi: 10.3390/curroncol13020005.
Eisbruch A, Harris J, Garden AS, Chao CK, Straube W, Harari PM, Sanguineti G, Jones CU, Bosch WR, Ang KK. Multi-institutional trial of accelerated hypofractionated intensity-modulated radiation therapy for early-stage oropharyngeal cancer (RTOG 00-22). Int J Radiat Oncol Biol Phys. 2010 Apr;76(5):1333-8. doi: 10.1016/j.ijrobp.2009.04.011. Epub 2009 Jun 18.
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.
Garden AS, Harris J, Eisbruch A, Chao KSC, Morrison WH, Harari PM, Swanson TA, Jones CU, Yom SS, Spencer SA, Scrimger R, Shenouda G, Shukla M, Lau HY, Mierzwa M, Torres-Saavedra P, Le QT. Final Report of NRG Oncology RTOG 0022: A Phase 1/2 Study of Conformal and Intensity Modulated Radiation for Oropharyngeal Cancer. Int J Radiat Oncol Biol Phys. 2023 Oct 1;117(2):333-340. doi: 10.1016/j.ijrobp.2023.02.057. Epub 2023 Mar 15. No abstract available.
Other Identifiers
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CDR0000068231
Identifier Type: -
Identifier Source: secondary_id
RTOG-H-0022
Identifier Type: -
Identifier Source: secondary_id
RTOG-0022
Identifier Type: -
Identifier Source: org_study_id
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