Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Overview

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).

Full Title of Study: “Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2011

Interventions

  • Drug: ramosetron
    • ramosetron 0.1mg q.d. SL on D1-5
  • Drug: ondansetron
    • ondansetron 8mg, b.i.d SL on D1-5

Arms, Groups and Cohorts

  • Experimental: RMS
    • ramosetron 0.1mg q.d. SL on D1-5
  • Active Comparator: ODS
    • ondansetron 8mg, b.i.d SL on D1-5

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Eui Kyu Chie/Assistant Clinical Professor, Department of Radiation Oncology, Seoul National University Hospital

References

Kim K, Chie EK, Jang JY, Kim SW, Oh DY, Im SA, Kim TY, Bang YJ, Ha SW. Ramosetron for the prevention of nausea and vomiting during 5-fluorouracil-based chemoradiotherapy for pancreatico-biliary cancer. Jpn J Clin Oncol. 2009 Feb;39(2):111-5. doi: 10.1093/jjco/hyn140. Epub 2008 Dec 5.

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