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

Study Overview
=================
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.

Official Title
-----------------
Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

Conditions
-----------------
Head and Neck Cancer, Radiation Toxicity

Intervention / Treatment
-----------------
* Drug: radioprotection
* Radiation: radiation therapy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: radioprotection|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, radiation toxicity