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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068231 | |||
| RTOG-H-0022 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radioprotection | Drug | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Acute salivary gland toxicity | ||
| Locoregional control | ||
| Whole mouth saliva output relative to pre-radiotherapy measurements | ||
| Acute mucositis and other acute and late toxicities |
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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
Surgery of the primary tumor or lymph nodes limited to incisional or excisional biopsies
No distant metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Avraham Eisbruch, MD | University of Michigan Rogel Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Cancer Research and Education | Phoenix | Arizona | 85013 | United States | ||
| UCSF Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17576443 | Background | 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. | |
| 19540060 | Result | 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. |
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| San Francisco |
| California |
| 94115 |
| United States |
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0385 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0010 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740-6395 | United States |
| Community Regional Cancer Center at Community Medical Center | Toms River | New Jersey | 08755 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| Community Cancer Center at Rutland Regional Medical Center | Rutland | Vermont | 05701 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| All Saints Cancer Center at All Saints Healthcare | Racine | Wisconsin | 53405 | United States |
| Stollery Children's Hospital at University of Alberta Hospital | Edmonton | Alberta | T6G 2R7 | Canada |
| Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2L 4MI | Canada |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| Result | 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. |
| 36925074 | Derived | 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. |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D011832 | Radiation Injuries |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014947 | Wounds and Injuries |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011835 | Radiation Protection |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D011870 | Radiologic Health |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013812 | Therapeutics |
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