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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004256

Enrollment

Unknown

Registered

2003-08-25

Start date

1997-10-31

Completion date

2006-07-31

Last updated

2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Oral Complications, Radiation Toxicity

Keywords

stage I laryngeal cancer, stage II laryngeal cancer, recurrent laryngeal cancer, oral complications, radiation toxicity

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.

Detailed description

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.

Interventions

BIOLOGICALsargramostim

PROCEDUREquality-of-life assessment

RADIATIONradiation therapy

Study design

Allocation

RANDOMIZED

Primary purpose

SUPPORTIVE_CARE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026