Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Lerisetron Compared With Granisetron in Preventing Nausea and Vomiting in Men Being Treated With Radiation Therapy for Stage I Seminoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Closed 18 to 70 Other SIMBEC-RD526/21494 EU-99027, NCT00004219

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.

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

Expected Enrollment

A total of 150 patients (50 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Simbec Research Limited

David P. Dearnaley, MD, FRCP, FRCR, Protocol chair		Ph: 44-20-8661-3271

Registry Information
Official Title		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
Registered in ClinicalTrials.gov		NCT00004219
Date Submitted to PDQ		1999-12-03
Information Last Verified		2007-06-01