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

Sponsor:	Royal Marsden NHS Foundation Trust
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
Head and Neck Cancer Oral Complications Radiation Toxicity	Biological: sargramostim Procedure: quality-of-life assessment Radiation: radiation therapy	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

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

U.S. FDA Resources

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 NHS Foundation Trust

Investigators

Study Chair:

J.M. Henk, MD

Royal Marsden NHS Foundation Trust

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:	August 19, 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

Additional relevant MeSH terms:

Mouth Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Mucositis
Gastrointestinal Diseases
Laryngeal Neoplasms
Neoplasms

Neoplasms by Site
Digestive System Diseases
Respiratory Tract Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Laryngeal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on February 08, 2010