Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Radiotherapy Induced Nausea and Vomiting Clinical Trial

Official title:

Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971399
• Other study ID #: RMS vs ODS for CRINV
• Secondary ID: 0808-011-252
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2009
• Last updated: February 24, 2011
• Start date: September 2009

Study information

• Verified date: February 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Radiotherapy Induced Nausea and Vomiting
• Vomiting

Intervention

Drug:
• ramosetron
ramosetron 0.1mg q.d. SL on D1-5
• ondansetron
ondansetron 8mg, b.i.d SL on D1-5

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response of RINV (no vomiting and no rescue medication)		4 weeks after medication	No