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

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 2; Phase 1

Conditions: Radiation Toxicity; Head and Neck Cancer

Treatments: Radiation: radiation therapy; Drug: radioprotection

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006360

RTOG-H-0022

CDR0000068231

RTOG-0022

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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