RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with radiation therapy. It is not yet known whether lerisetron is more effective than granisetron in preventing nausea and vomiting.

PURPOSE: Randomized phase III trial to compare the effectiveness of lerisetron with that of granisetron in preventing nausea and vomiting in men who are being treated with radiation therapy for stage I seminoma.

OBJECTIVES: I. Compare the efficacy and safety of lerisetron versus granisetron in the prevention of radiotherapy induced nausea and vomiting in men with stage I testicular seminoma.

PROTOCOL 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 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.

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of stage I seminoma
• No clinical evidence of brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: No concurrent corticosteroids except topical 1% hydrocortisone or equivalent
• Radiotherapy: No prior radiotherapy
• Surgery: Not specified
• Other: At least 48 hours since prior antiemetics; No other concurrent antiemetics

--Patient Characteristics--

• Age: 18 to 70
• Sex: Male
• Performance status: Not specified
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: No significant hepatic impairment
• Renal: No significant renal impairment
• Other: No known hypersensitivity to serotonin antagonists; No prior anticipatory emesis; No communication impairments (e.g., language problem, poor mental development, or impaired cerebral function) that would preclude study