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

Sponsor

Simbec Research (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00004219

Collaborator

(none)

150

Enrollment

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nausea and Vomiting Testicular Germ Cell Tumor	Drug: granisetron hydrochloride Drug: lerisetron Radiation: radiation therapy	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Primary Purpose:

Supportive Care

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Diagnosis of stage I seminoma No clinical evidence of brain metastases

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