Radiation Therapy in Treating Patients With Stage II or Stage III Oropharyngeal Cancer

Radiation Therapy Oncology Group

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Head and Neck Cancer Radiation Toxicity

Interventions

radioprotectionDRUG

radiation therapyRADIATION

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (18)

Foundation for Cancer Research and Education

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Acute salivary gland toxicity

Locoregional control

Whole mouth saliva output relative to pre-radiotherapy measurements

Acute mucositis and other acute and late toxicities

Data from ClinicalTrials.gov

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