Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer
This study has been completed.
Sponsor:
Radiation Therapy Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006360
First received: October 4, 2000
Last updated: March 25, 2010
Last verified: October 2005
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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 |
|---|---|---|
|
Head and Neck Cancer Radiation Toxicity |
Drug: radioprotection Radiation: radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Acute salivary gland toxicity [ Designated as safety issue: Yes ]
- Locoregional control [ Designated as safety issue: No ]
- Whole mouth saliva output relative to pre-radiotherapy measurements [ Designated as safety issue: No ]
- Acute mucositosis and other acute and late toxicities [ Designated as safety issue: Yes ]
| Study Start Date: | February 2001 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically proven stage II or III (T1-T2, N0-N1) squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or palate)
- Lymph nodes in both sides of neck at risk of metastatic disease and require radiotherapy
- Patients upstaged by imaging to N2 are eligible
Measurable or evaluable disease
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006360
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 | |
| 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 | |
| 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 | |
| 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 | |
| Canada, Alberta | |
| Stollery Children's Hospital at University of Alberta Hospital | |
| Edmonton, Alberta, Canada, T6G 2R7 | |
| Canada, Quebec | |
| McGill Cancer Centre at McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L 4MI | |
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
| Study Chair: | Avraham Eisbruch, MD | University of Michigan Cancer Center |
More Information
Additional Information:
Publications:
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.
| ClinicalTrials.gov Identifier: | NCT00006360 History of Changes |
| Other Study ID Numbers: | CDR0000068231, RTOG-0022, RTOG-H-0022, RTOG-DEV-1065 |
| Study First Received: | October 4, 2000 |
| Last Updated: | March 25, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx radiation toxicity |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Oropharyngeal Neoplasms Radiation Injuries Neoplasms by Site Neoplasms Pharyngeal Neoplasms |
Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013