Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004256|
Recruitment Status : Completed
First Posted : August 25, 2003
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Oral Complications Radiation Toxicity||Biological: sargramostim Procedure: quality-of-life assessment Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Study Completion Date :||July 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004256
|Royal Marsden NHS Trust|
|London, England, United Kingdom, SW3 6JJ|
|Study Chair:||J.M. Henk, MD||Royal Marsden NHS Foundation Trust|