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	Treatment or Intervention	Phase
stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx radiation toxicity	Procedure: radiation therapy  Procedure: radioprotection  Procedure: supportive care/therapy	Phase I Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Arizona
      Foundation for Cancer Research and Education, Phoenix,  Arizona,  85013,  United States; Recruiting
California
      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115,  United States; Recruiting
Florida
      University of Florida Shands Cancer Center, Gainesville,  Florida,  32610-0385,  United States; Recruiting
Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0010,  United States; Recruiting
Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
New Jersey
      Community Medical Center, Toms River,  New Jersey,  08755,  United States; Recruiting
      Monmouth Medical Center, Long Branch,  New Jersey,  07740-6395,  United States; Recruiting
Pennsylvania
      Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107-5541,  United States; Recruiting
Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
Utah
      Dixie Regional Medical Center, Saint George,  Utah,  84770,  United States; Recruiting
      LDS Hospital, Salt Lake City,  Utah,  84143,  United States; Recruiting
Vermont
      Community Cancer Center at Rutland Regional Medical Center, Rutland,  Vermont,  05701,  United States; Recruiting
Wisconsin
      All Saints Cancer Center at All Saints Healthcare, Racine,  Wisconsin,  53405,  United States; Recruiting
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Canada, Alberta
      University of Alberta, Edmonton,  Alberta,  T6G 2R7,  Canada; Recruiting
Canada, Quebec
      Centre Hospitalier de l'Universite de Montreal, Montreal,  Quebec,  H2L 4MI,  Canada; Recruiting
      McGill Cancer Centre at McGill University, Montreal,  Quebec,  H2W 1S6,  Canada; Recruiting

Study chairs or principal investigators

Avraham Eisbruch, MD,  Study Chair,  University of Michigan Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068231; RTOG-0022; RTOG-H-0022; RTOG-DEV-1065; NCT00006360
Record last reviewed:  May 2004
Last Updated:  April 5, 2005
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006360
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08