Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

February 24, 2011 updated by: Seoul National University Hospital

Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RMS
ramosetron 0.1mg q.d. SL on D1-5
Drug: ramosetron
ramosetron 0.1mg q.d. SL on D1-5
Active Comparator: ODS
ondansetron 8mg, b.i.d SL on D1-5
Drug: ondansetron
ondansetron 8mg, b.i.d SL on D1-5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete response of RINV (no vomiting and no rescue medication)
Time Frame: 4 weeks after medication
4 weeks after medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimate)

September 3, 2009

Study Record Updates

Last Update Posted (Estimate)

February 28, 2011

Last Update Submitted That Met QC Criteria

February 24, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMS vs ODS for CRINV
  • 0808-011-252

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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