Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer

Conditions
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Head and Neck Cancer, Oral Complications, Radiation Toxicity

Intervention / Treatment
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* Biological: sargramostim
* Procedure: quality-of-life assessment
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: sargramostim|nan|
|Procedure: quality-of-life assessment|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I laryngeal cancer, stage II laryngeal cancer, recurrent laryngeal cancer, oral complications, radiation toxicity