Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
NCT00008398 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2013-11-19
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.
Conditions
- Head and Neck Cancer
- Oral Complications
- Radiation Toxicity
Interventions
- BIOLOGICAL
-
sargramostim
- PROCEDURE
-
quality-of-life assessment
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Radiation Therapy Oncology Group
lead NETWORK
Principal Investigators
-
Francis G. LeVeque, DDS · Barbara Ann Karmanos Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-10-31
- Primary Completion
- 2004-03-31
Countries
- United States
- Canada
Study Locations
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