A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis
OBJECTIVES:
- Compare the effectiveness of ondansetron with or without dexamethasone as prophylaxis
for radiation-induced emesis and nausea in patients receiving upper abdominal
radiotherapy.
- Compare toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to radiotherapy field description (whole abdomen and pelvis vs
partial abdomen and pelvis vs partial abdomen only). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive oral ondansetron twice daily and oral dexamethasone daily for
5-7 days concurrently with the first 5 fractions of radiotherapy.
- Arm II: Patients receive oral ondansetron twice daily and oral placebo daily for 5-7
days concurrently with the first 5 fractions of radiotherapy.
Treatment continues in both arms in the absence of disease progression or unacceptable
toxicity.
Quality of life is assessed at baseline, prior to starting radiotherapy if more than 5 days
since randomization, prior to the 5th and 15th fractions of radiotherapy, and 1 month after
completion of radiotherapy.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 100-200 patients (50-100 per arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Rebecca Wong, MD
Study Chair
Princess Margaret Hospital, Canada
United States: Federal Government
SC19
NCT00016380
February 2001
February 2009
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