NCT00971399

Brief Summary

The purpose of this study is:

  1. 1.To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer.
  2. 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Last Updated

February 28, 2011

Status Verified

February 1, 2011

Enrollment Period

1.4 years

First QC Date

September 2, 2009

Last Update Submit

February 24, 2011

Conditions

Radiotherapy Induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

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

    4 weeks after medication

Study Arms (2)

RMS

EXPERIMENTAL

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

Drug: ramosetron

ODS

ACTIVE COMPARATOR

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

Drug: ondansetron

Interventions

ramosetronDRUG

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

RMS
ondansetronDRUG

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

ODS

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AJCC 1-3 staged gastrointestinal cancer patient
  • patient undergoing radiotherapy as treatment
  • age 20 yr and higher
  • ECOG 0-2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related 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.

    PMID: 19060294BACKGROUND

MeSH Terms

Conditions

Vomiting

Interventions

ramosetronOndansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 3, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2011

Last Updated

February 28, 2011

Record last verified: 2011-02

Locations

KR(1)