Overview
Lerisetron Compared With Granisetron in Preventing Nausea and Vomiting in Men Being Treated With Radiation Therapy for Stage I Seminoma
Status:
Unknown status
Unknown status
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Simbec ResearchTreatments:
Granisetron
Criteria
DISEASE CHARACTERISTICS: Diagnosis of stage I seminoma No clinical evidence of brainmetastases
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
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