Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as sargramostim may protect normal cells from the side effects of radiation therapy.
PURPOSE: Randomized phase II trial to determine the effectiveness of sargramostim in preventing mucositis in patients who are receiving radiation therapy for laryngeal cancer.
|Head and Neck Cancer Oral Complications Radiation Toxicity||Biological: sargramostim Procedure: quality-of-life assessment Radiation: radiation therapy||Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer|
|Study Start Date:||October 1997|
|Study Completion Date:||July 2006|
- Determine the efficacy of sargramostim (GM-CSF) in reducing the duration and severity of mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma.
- Determine the effect of GM-CSF on quality of life aspects of these patients as assessed by nutritional status, analgesic use, and days in the hospital.
OUTLINE: This is a randomized study.
Patients receive radiotherapy in 16 fractions over 21 days. Patients are randomly allocated to one of two treatment arms before scheduled radiotherapy begins.
- Arm I: Patients receive sargramostim (GM-CSF) SC daily for 14 days beginning on day 14 of the course of radiotherapy.
- Arm II: Patients do not receive GM-CSF. Patients are followed weekly until mucositis is healed, as well as at weeks 2 and 6 following the end of radiotherapy.
PROJECTED ACCRUAL: A total of 34 patients (17 per arm) will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004256
|Royal Marsden NHS Trust|
|London, England, United Kingdom, SW3 6JJ|
|Study Chair:||J.M. Henk, MD||Royal Marsden NHS Foundation Trust|