Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Natural history/Epidemiology, Treatment Closed 18 and over NCI RTOG-0225 RTOG-0225, NCT00057785

Objectives

1. Determine the rate of late xerostomia in patients with nasopharyngeal cancer treated with intensity-modulated radiotherapy (IMRT) with or without chemotherapy.
2. Correlate reduction of side effects on salivary flow with compliance in patients treated with these regimens.
3. Determine the rate of local-regional control, distant metastasis, and disease-free and overall survival of patients treated with these regimens.
4. Determine the acute and late toxicity of these regimens in these patients.
5. Determine chemotherapy compliance in patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 4,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Not specified

Renal

• Creatinine no greater than 1.6 mg/dL
• Creatinine clearance at least 60 mL/min

Other

• Not pregnant*
• Negative pregnancy test*
• 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]

Expected Enrollment

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

Outcomes

Transportability of intensity-modulated radiotherapy technique in a multi0institytuibal setting
Intensity-modulated radiotherapy treatment compliance rate

Rate of xerostomia at 1 year (grade ≥ 2)
Rate of locoregional control at 2 years
Whole mouth saliva output relative to pretreatment measurements
Other acute and late toxicities
Chemotherapy compliance

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.

Lee NY, Harris J, Garden A, et al.: Phase II multi-institutional study of IMRT ± chemotherapy for nasopharyngeal carcinoma (RTOG 0225): preliminary results. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-23, S13-14, 2007.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Nancy Lee, MD, Protocol chair		Ph: 212-639-3341; 800-525-2225

Registry Information
Official Title		A Phase II Study Of Intensity Modulated Radiation Therapy (IMRT) +/- Chemotherapy For Nasopharyngeal Cancer
Trial Start Date		2003-02-21
Registered in ClinicalTrials.gov		NCT00057785
Date Submitted to PDQ		2002-11-20
Information Last Verified		2005-11-28
NCI Grant/Contract Number		CA21661

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