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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004256
• Other study ID #: CDR0000067503
• Secondary ID: RMNHS-GMCSFEU-99
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2000
• Last updated: November 5, 2013
• Start date: October 1997
• Est. completion date: July 2006

Study information

• Verified date: August 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Laryngeal Neoplasms
• Oral Complications
• Radiation Injuries
• Radiation Toxicity

Intervention

Biological:
• sargramostim

Procedure:
• quality-of-life assessment

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Trust	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

McAleese JJ, Bishop KM, A'Hern R, Henk JM. Randomized phase II study of GM-CSF to reduce mucositis caused by accelerated radiotherapy of laryngeal cancer. Br J Radiol. 2006 Jul;79(943):608-13. — View Citation