Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx

• WHO I-III

• No stage IVC disease

• No evidence of distant metastasis

• Measurable or evaluable disease

• Must have been treated with primary radiotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• White blood cell count (WBC) at least 4,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Not specified

Renal

• Creatinine no greater than 1.6 mg/dL

• Creatinine clearance at least 60 mL/min

Other

• Not pregnant (If stage T2b or greater or node-positive disease)

• Negative pregnancy test (If stage T2b or greater or node-positive disease)

• No other prior head and neck cancer

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• No active untreated infection

• No other major medical or psychiatric illness that would preclude study entry

• Nutritional and general physical condition compatible with radiotherapy NOTE: *If stage T2b or greater or node-positive disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 6 months since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• More than 6 months since prior radiotherapy for head and neck cancer

Surgery

• No prior head and neck surgery to the primary tumor or lymph nodes except incisional or excisional biopsies

Other

• No other concurrent experimental therapy for cancer

• No amifostine or pilocarpine during or for 3 months after radiotherapy