Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Radiotherapy Induced Nausea and Vomiting

Treatments: Drug: ramosetron; Drug: ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT00971399

0808-011-252

RMS vs ODS for CRINV

Details and patient eligibility

About

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).

Enrollment: 172 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 2 patient groups

RMS

Experimental group

Description:

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

Treatment:

Drug: ramosetron

ODS

Active Comparator group

Description:

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

Treatment:

Drug: ondansetron