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



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

For Condition: Laryngeal Cancer
Status: Completed
Sponsor(s): Royal Marsden NHS Trust ,
Synopsis: 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.
Details: OBJECTIVES: I. Determine the efficacy of sargramostim (GM-CSF) in reducing the duration and severity of mucositis resulting from accelerated radiotherapy in patients with laryngeal carcinoma. II. 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 20 Years/80 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
J.M.Henk,  Study Chair,  Royal Marsden NHS Trust

Royal Marsden NHS Trust
London,  England,  SW3 6JJ
United Kingdom
 


Additional Information:
Study ID Numbers:  CDR0000067503;  RMNHS-GMCSF,EU-99041
Study Start Date: October 1997
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004256

Other Laryngeal Cancer Studies:
1. Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery

2. Isotretinoin, Interferon alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer

3. Chemotherapy and Radiation Therapy in Treating Patients With Head and Neck Cancer

4. Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia

5. Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

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