Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting
NCT ID: NCT00971399
Last Updated: 2011-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
172 participants
INTERVENTIONAL
2009-09-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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RMS
ramosetron 0.1mg q.d. SL on D1-5
ramosetron
ramosetron 0.1mg q.d. SL on D1-5
ODS
ondansetron 8mg, b.i.d SL on D1-5
ondansetron
ondansetron 8mg, b.i.d SL on D1-5
Interventions
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ramosetron
ramosetron 0.1mg q.d. SL on D1-5
ondansetron
ondansetron 8mg, b.i.d SL on D1-5
Eligibility Criteria
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Inclusion Criteria
* patient undergoing radiotherapy as treatment
* age 20 yr and higher
* ECOG 0-2
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Department of Radiation Oncology, Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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0808-011-252
Identifier Type: -
Identifier Source: secondary_id
RMS vs ODS for CRINV
Identifier Type: -
Identifier Source: org_study_id