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

Royal Marsden NHS Foundation Trust

Status and phase: Completed; Phase 2

Conditions: Radiation Toxicity; Oral Complications; Head and Neck Cancer

Treatments: Biological: sargramostim; Radiation: radiation therapy; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT00004256

EU-99041

RMNHS-GMCSF

CDR0000067503

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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