Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

Phase 3

Completed

• Conditions: Oral Complications; Radiation Toxicity; Head and Neck Cancer

• Registration Number: NCT00008398
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

RATIONALE: Sargramostim may lessen symptoms of mucositis in patients receiving radiation therapy for head and neck cancer. It is not yet known if sargramostim is more effective than no treatment in reducing mucositis caused by radiation therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of sargramostim in decreasing mucositis in patients who are receiving radiation therapy for head and neck cancer.

Detailed Description

OBJECTIVES:

* Determine the efficacy of sargramostim (GM-CSF) in terms of reducing the severity and expected duration of radiotherapy-induced oral mucositis in patients with head and neck cancer receiving radiotherapy.

* Determine the correlation between reduced mucosal injury and quality of life improvement in patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to concurrent cisplatin chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive radiotherapy once daily five days a week for 6-7 weeks. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) three times a week (except on days if receiving concurrent cisplatin) beginning 1 week prior to radiotherapy and continuing until 2 weeks after completion of radiotherapy for a total of approximately 9 weeks.

* Arm II: Patients receive radiotherapy as in arm I. Patients also receive placebo SC on the same schedule as GM-CSF in arm I.

Quality of life is assessed at baseline, and then at 3, 6, and 12 months.

Patients are followed at 3, 6 and 11 months.

PROJECTED ACCRUAL: A total of 126 patients (63 per arm) will be accrued within 1.2-1.4 years.

Study Timeline

• Study Start: 2000-10
• Study First Submitted: 2001-01-06
• Study First Submitted QC: 2003-06-04
• Study First Posted: 2003-06-05
• Primary Completion: 2004-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (236)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Huntsville Hospital System; 🇺🇸 Huntsville, Alabama, United States

Comprehensive Cancer Institute of Huntsville; 🇺🇸 Huntsville, Alabama, United States

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

Alabama Oncology, LLC; 🇺🇸 Montgomery, Alabama, United States

Radiation Oncology Associates of West Alabama; 🇺🇸 Tuscaloosa, Alabama, United States

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

Mount Diablo Medical Center; 🇺🇸 Concord, California, United States

Cancer Center and Beckman Research Institute, City of Hope; 🇺🇸 Duarte, California, United States

California Cancer Center; 🇺🇸 Fresno, California, United States

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