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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   Information provided by National Cancer Institute (NCI)
First Received: January 28, 2000   Last Updated: August 19, 2009   History of Changes

January 28, 2000
August 19, 2009
October 1997
 
 
 
Complete list of historical versions of study NCT00004256 on ClinicalTrials.gov Archive Site
 
 
 
Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer
Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of 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.

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.

Phase II
Interventional
Supportive Care, Randomized, Active Control
  • Head and Neck Cancer
  • Oral Complications
  • Radiation Toxicity
  • Biological: sargramostim
  • Procedure: quality-of-life assessment
  • Radiation: radiation therapy
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00004256
 
CDR0000067503, RMNHS-GMCSF, EU-99041
Royal Marsden - London
 
Study Chair: J.M. Henk, MD Royal Marsden - London
National Cancer Institute (NCI)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP