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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004256
First Posted: August 25, 2003
Last Update Posted: November 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00004256     History of Changes
Other Study ID Numbers: CDR0000067503
RMNHS-GMCSF
EU-99041
First Submitted: January 28, 2000
First Posted: August 25, 2003
Last Update Posted: November 6, 2013
Last Verified: August 2006

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
Mucositis
Radiation Injuries
Laryngeal Neoplasms
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Wounds and Injuries
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases