Head and Neck Cancer, Radiation Toxicity
Conditions
Keywords
stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, radiation toxicity
Brief summary
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.
Detailed description
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.
Interventions
DRUGradioprotection
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | 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 | — |
Countries
Canada, United States
Outcome results
None listed