Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Seoul National University Hospital172 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

172

Conditions

Radiotherapy Induced Nausea and Vomiting

Interventions

ramosetronDRUG

ramosetron 0.1mg q.d. SL on D1-5

ondansetronDRUG

ondansetron 8mg, b.i.d SL on D1-5

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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 (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

complete response of RINV (no vomiting and no rescue medication)

Time frame: 4 weeks after medication

Data from ClinicalTrials.gov

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