Clinical trial · Interventional
Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting
Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer
NCT00971399CI-TRIAL-00004477completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiotherapy Induced Nausea and Vomiting | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ondansetron | Drug | — | UNRESOLVED |
| ramosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RMS
- description
- ramosetron 0.1mg q.d. SL on D1-5
- interventionNames
- Drug: ramosetron
- type
- ACTIVE_COMPARATOR
- label
- ODS
- description
- ondansetron 8mg, b.i.d SL on D1-5
- interventionNames
- Drug: ondansetron
Primary outcomes (1)
- measure
- complete response of RINV (no vomiting and no rescue medication)
- timeFrame
- 4 weeks after medication
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDKim 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. PMID 19060294