Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of Laryngeal Cancer
20 Years
80 Years
Both
Head and Neck Cancer, Oral Complications, Radiation Toxicity
Trial Information
Randomised Phase II Study of GM-CSF to Reduce Severity of Mucositis Caused by Accelerated Radiotherapy of 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Principal Investigator
J.M. Henk, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000067503
NCT ID:
NCT00004256
Start Date:
October 1997
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Oral Complications
- Radiation Toxicity
- stage I laryngeal cancer
- stage II laryngeal cancer
- recurrent laryngeal cancer
- oral complications
- radiation toxicity
- Laryngeal Neoplasms
- Head and Neck Neoplasms
- Radiation Injuries
- Mucositis
Name | Location |
|---|
