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Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Information source: Seoul National University Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Radiotherapy Induced Nausea and Vomiting

Intervention: ramosetron (Drug); ondansetron (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Seoul National University Hospital

Overall contact:
Eui Kyu Chie, MD, Phone: 82-2-2072-3705, Email: ekchie93@snu.ac.kr

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).

Clinical Details

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

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

Primary outcome: complete response of RINV (no vomiting and no rescue medication)

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Eui Kyu Chie, MD, Phone: 82-2-2072-3705, Email: ekchie93@snu.ac.kr

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Eui Kyu Chie, MD, Principal Investigator
Yung-Jue Bang, MD, Sub-Investigator
Tae-You Kim, MD, Sub-Investigator
Seock-Ah Im, MD, Sub-Investigator
Do-Youn Oh, MD, Sub-Investigator
Se-Won Han, MD, Sub-Investigator
Additional Information

Related publications:

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. Epub 2008 Dec 5.

Starting date: September 2009
Last updated: September 2, 2009

Page last updated: October 04, 2010

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