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

NCT ID: NCT00004256

Last Updated: 2013-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-10-31
• Study Completion Date: 2006-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

sargramostim

Intervention Type: BIOLOGICAL

quality-of-life assessment

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

J.M. Henk, MD

Role: STUDY_CHAIR

Royal Marsden NHS Foundation Trust

Locations

Royal Marsden NHS Trust

London, England, United Kingdom

Countries

United Kingdom

References

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. doi: 10.1259/bjr/55190439.

Reference Type: RESULT

PMID: 16823067 (View on PubMed)

Other Identifiers

RMNHS-GMCSF

Identifier Type: -

Identifier Source: secondary_id

EU-99041

Identifier Type: -

Identifier Source: secondary_id

CDR0000067503

Identifier Type: -

Identifier Source: org_study_id