Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting
Information source: Seoul National University Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Radiotherapy Induced Nausea and Vomiting
Intervention: ramosetron (Drug); ondansetron (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Seoul National University Hospital Overall contact:
Eui Kyu Chie, MD, Phone: 82-2-2072-3705, Email: ekchie93@snu.ac.kr
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).
Clinical Details
Official title: Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: complete response of RINV (no vomiting and no rescue medication)
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Eui Kyu Chie, MD, Phone: 82-2-2072-3705, Email: ekchie93@snu.ac.kr
Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Eui Kyu Chie, MD, Principal Investigator
Yung-Jue Bang, MD, Sub-Investigator
Tae-You Kim, MD, Sub-Investigator
Seock-Ah Im, MD, Sub-Investigator
Do-Youn Oh, MD, Sub-Investigator
Se-Won Han, MD, Sub-Investigator
Additional Information
Related publications: 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. Epub 2008 Dec 5.
Starting date: September 2009
Last updated: September 2, 2009
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