Sargramostim to Prevent Mucositis in Patients Receiving Radiation Therapy for Laryngeal Cancer - Full Text View

Sponsored by:	Royal Marsden - London
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004256

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
Cancer-Related Problem/Condition Head and Neck Cancer	Biological: sargramostim Procedure: quality-of-life assessment Radiation: radiation therapy	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

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

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

Study Start Date:

October 1997

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

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

Locations

United Kingdom, England
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ

Sponsors and Collaborators

Royal Marsden - London

Investigators

Study Chair:

J.M. Henk, MD

Royal Marsden - London

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000067503, RMNHS-GMCSF, EU-99041
Study First Received:	January 28, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004256 History of Changes
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
quality of life

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Respiratory Tract Diseases
Mucositis
Laryngeal Carcinoma

Head and Neck Neoplasms
Quality of Life
Laryngeal Neoplasms
Laryngeal Diseases
Recurrence

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Otorhinolaryngologic Diseases
Neoplasms by Site
Otorhinolaryngologic Neoplasms

Respiratory Tract Diseases
Head and Neck Neoplasms
Laryngeal Neoplasms
Laryngeal Diseases

ClinicalTrials.gov processed this record on May 07, 2009