A Study to Investigate the Efficacy and Tolerability of Two Dose Levels of Lerisetron Compared With Granisetron in Patients Receiving Radiotherapy for Stage I Seminoma
OBJECTIVES: I. Compare the efficacy and safety of lerisetron versus granisetron
hydrochloride in the prevention of radiotherapy induced nausea and vomiting in men with
stage I testicular seminoma.
OUTLINE: This is a randomized, double blind, parallel, multicenter study. Patients are
randomized to one of three treatment arms. Arm I: Patients receive oral lerisetron with an
oral placebo once daily for 14 days. Arm II: Patients receive oral lerisetron once daily for
14 days. Arm III: Patients receive oral granisetron hydrochloride once daily for 14 days. At
1-2 hours following antiemetics, all patients undergo concurrent daily radiotherapy for at
least 10 out of 14 days. Patients are followed daily for 10 days.
PROJECTED ACCRUAL: A total of 150 patients (50 per treatment arm) will be accrued for this
study.
Interventional
Allocation: Randomized, Primary Purpose: Supportive Care
David P. Dearnaley, MD, FRCP, FRCR
Study Chair
Royal Marsden NHS Foundation Trust
United States: Federal Government
CDR0000067456
NCT00004219
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