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

This study is ongoing, but not recruiting participants.
Study NCT00004256.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
Official Title † Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer
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.
Study Phase Phase II
Study Type † Interventional
Study Design † Supportive Care, Randomized, Active Control
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Cancer-Related Problem/Condition
Head and Neck Cancer
Intervention † Drug: sargramostim
Procedure: quality-of-life assessment
Procedure: radiation therapy
MEDLINE PMIDs 16823067
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Active, not recruiting
Enrollment †
Start Date † October 1997
Completion Date
Eligibility 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
Gender Both
Ages 20 Years to 80 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United Kingdom
Administrative Information Fields
NCT ID † NCT00004256
Organization ID CDR0000067503
Secondary IDs †† RMNHS-GMCSF, EU-99041
Study Sponsor † Royal Marsden - London
Collaborators ††
Investigators †
Study Chair:     J.M. Henk, MD     Royal Marsden - London    
Information Provided By National Cancer Institute (NCI)
Verification Date August 2006
First Received Date † January 28, 2000
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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