A Randomized Phase III Double-Blind Study Of Ondansetron And Dexamethasone Versus Ondansetron And Placebo In The Prophylaxis Of Radiation-Induced Emesis
- Compare the effectiveness of ondansetron with or without dexamethasone as prophylaxis
for radiation-induced emesis and nausea in patients receiving upper abdominal
- 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
- 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
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
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Rebecca Wong, MD
Princess Margaret Hospital, Canada
United States: Federal Government