Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004219
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2000-01-28
Brief Title:
Lerisetron Compared With Granisetron in Preventing Nausea and Vomiting in Men Being Treated With Radiation Therapy for Stage I Seminoma
Sponsor:
Simbec Research
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-99027 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067456 | REGISTRY | None | None |