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

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).

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