Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Phase 3

Completed

• Conditions: Radiotherapy Induced Nausea and Vomiting
• Interventions: Drug: ondansetron; Drug: ramosetron

• Registration Number: NCT00971399
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is:

1. To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer.

2. To verify an improvement of 20% in complete response rate in term of radiotherapy induced nausea and vomiting (from 60% with ondansetron to 80% with ramosetron).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Last Update Submitted: 2011-02-24
• Last Update Posted: 2011-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• AJCC 1-3 staged gastrointestinal cancer patient
• patient undergoing radiotherapy as treatment
• age 20 yr and higher
• ECOG 0-2

Exclusion Criteria

• age < 20
• ECOG 3-4
• patient experiencing nausea or vomiting prior to accrual
• patient under antiemetic medication
• patient under steroid medication (topical or inhalant steroid application are exceptional)
• patient under opioid medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ODS	ondansetron	ondansetron 8mg, b.i.d SL on D1-5
RMS	ramosetron	ramosetron 0.1mg q.d. SL on D1-5

Primary Outcome Measures

Name	Time	Method
complete response of RINV (no vomiting and no rescue medication)	4 weeks after medication

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of