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

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 2

Conditions: Radiation Toxicity; Oral Complications of Radiation Therapy; Head and Neck Cancer

Treatments: Radiation: Intensity modulated radiation therapy; Drug: fluorouracil; Drug: cisplatin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00057785

RTOG-0225

CDR0000269314

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

• Determine the transportability of IMRT to a multi-institutional setting.
• Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated with intensity-modulated radiotherapy (IMRT) with or without chemotherapy.
• Correlate reduction of side effects on salivary flow with compliance in patients treated with these regimens.
• Determine the rate of local-regional control, distant metastasis, and disease-free and overall survival of patients treated with these regimens.
• Determine the acute and late toxicity of these regimens in these patients.
• Determine chemotherapy compliance in patients treated with these regimens.

OUTLINE: Patients undergo daily intensity-modulated radiotherapy (IMRT) 5 days a week for approximately 6.5 weeks (total of 33 fractions) in the absence of disease progression or unacceptable toxicity.

Patients with stage T2b or greater and/or node-positive disease receive cisplatin IV over 20-30 minutes on days 1, 22, and 43 concurrently with IMRT followed by cisplatin IV over 20-30 minutes and fluorouracil IV over 96 hours starting on days 71, 99, and 127.

Quality of life is assessed through saliva measurement at baseline and then at 3, 6, and 12 months after IMRT.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 64 patients will be accrued for this study within 36-40 months.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

68 participants in 1 patient group

IMRT +/- chemotherapy

Experimental group

Description:

Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+

Treatment:

Radiation: Intensity modulated radiation therapy

Drug: fluorouracil

Drug: cisplatin