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Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Primary Purpose

Radiotherapy Induced Nausea and Vomiting

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ramosetron

ondansetron

About this trial

This is an interventional prevention trial for Radiotherapy Induced Nausea and Vomiting

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RMS

ODS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00971399

First Posted

September 2, 2009

Last Updated

February 24, 2011

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00971399

Brief Title

Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is: To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiotherapy Induced Nausea and Vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RMS

Arm Type

Experimental

Arm Description

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

Arm Title

ODS

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ramosetron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ondansetron

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks after medication

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

19060294

Citation

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.

Results Reference

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Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting

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