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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004256
First received: January 28, 2000
Last updated: November 5, 2013
Last verified: August 2006
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Oral Complications
Radiation Toxicity
Biological: sargramostim
Procedure: quality-of-life assessment
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 1997
Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004256

Locations
United Kingdom
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Study Chair: J.M. Henk, MD Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00004256     History of Changes
Other Study ID Numbers: CDR0000067503, RMNHS-GMCSF, EU-99041
Study First Received: January 28, 2000
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I laryngeal cancer
stage II laryngeal cancer
recurrent laryngeal cancer
oral complications
radiation toxicity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Laryngeal Neoplasms
Radiation Injuries
Laryngeal Diseases
Neoplasms
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014