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NCT Number: NCT00004256

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Oral Complications Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Radiation Injuries Radiation Toxicity Respiratory Tract Diseases Respiratory Tract Neoplasms Wounds and Injuries

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sargramostim

Biological

quality-of-life assessment

Procedure

radiation therapy

Radiation

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
1997
Study completion
2006
First posted
Aug 25, 2003
Registry last updated
Nov 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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