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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IINatural history/Epidemiology, TreatmentCompleted18 and overNCI, OtherRTOG-0225
CDR0000269314, NCT00057785

Trial Description


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.

Further Study Information


  • 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.

Eligibility Criteria


  • Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx
  • No stage IVC disease
  • No evidence of distant metastasis
  • Measurable or evaluable disease
  • Must have been treated with primary radiotherapy



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • White blood cell count (WBC) at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Not specified


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


  • 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


Biologic therapy

  • Not specified


  • More than 6 months since prior chemotherapy

Endocrine therapy

  • Not specified


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


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


  • No other concurrent experimental therapy for cancer
  • No amifostine or pilocarpine during or for 3 months after radiotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

  • National Cancer Institute
Nancy Lee, MD, Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00057785
ClinicalTrials.gov processed this data on April 09, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.