Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer
sargramostim
+ quality-of-life assessment
+ radiation therapy
Laryngeal Diseases+8
+ Neoplasms
+ Neoplasms by Site
Supportive Care Study
Summary
Study start date: October 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Diagnosis of laryngeal cancer with intention to treat by radiotherapy using a 16 fraction 3 week scheme Stage I or II No known CNS disease PATIENT CHARACTERISTICS: Age: 20 to 80 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Hepatic function normal Renal: Renal function normal Other: Not pregnant or nursing No serious active infection requiring antibiotic therapy No autoimmune disease No known seizures No psychosocial factors that would preclude study compliance No allergies to sargramostim (GM-CSF) Willingness to cooperate for regular mirror examination of the larynx PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No prior or concurrent corticosteroids No concurrent hormonal therapy Radiotherapy: See Disease Characteristics Surgery: No major organ allografts Other: No other concurrent investigational drugs
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location