Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
Study Details
Study Description
Brief Summary
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 |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
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Determine the efficacy of sargramostim (GM-CSF) in reducing the duration and severity of mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma.
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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.
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Arm I: Patients receive sargramostim (GM-CSF) SC daily for 14 days beginning on day 14 of the course of radiotherapy.
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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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
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No known seizures
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No psychosocial factors that would preclude study compliance
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Marsden NHS Trust | London | England | United Kingdom | SW3 6JJ |
Sponsors and Collaborators
- Royal Marsden NHS Foundation Trust
Investigators
- Study Chair: J.M. Henk, MD, Royal Marsden NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000067503
- RMNHS-GMCSF
- EU-99041