Radiotherapy Induced Nausea and VomitingPhase 3NCT00971399
Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting
A Phase 3 study testing ramosetron and ondansetron in people with Radiotherapy Induced Nausea and Vomiting, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Radiotherapy Induced Nausea and Vomiting
- What is being tested?
- ramosetron and ondansetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AJCC 1-3 staged gastrointestinal cancer patient
- patient undergoing radiotherapy as treatment
- age 20 yr and higher
- ECOG 0-2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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).
- Conditions
- Radiotherapy Induced Nausea and Vomiting
- Being tested
- ramosetron, ondansetron
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramosetronDrug
ramosetron 0.1mg q.d. SL on D1-5
ondansetronDrug
ondansetron 8mg, b.i.d SL on D1-5
| Study group | Role | What they receive |
|---|---|---|
| RMS | Experimental | ramosetron 0.1mg q.d. SL on D1-5 Receives: Drug: ramosetron |
| ODS | Active comparator | ondansetron 8mg, b.i.d SL on D1-5 Receives: Drug: ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response of RINV (no vomiting and no rescue medication)
Measured: 4 weeks after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiotherapy Induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971399
- Sponsor's protocol ID
- RMS vs ODS for CRINV
- Other IDs
- 0808-011-252
- Status last verified
- Feb 2011
- First submitted
- 2 Sep 2009
- Last updated
- 28 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1093/jjco/hyn140. Epub 2008 Dec 5.
PubMed 19060294
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT00971399
- Acronym / sponsor ID
- RMS vs ODS for CRINV
- Conditions
- Radiotherapy Induced Nausea and Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2011 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RMS | Experimental | Drug: ramosetronramosetron 0.1mg q.d. SL on D1-5 |
| ODS | Active comparator | Drug: ondansetronondansetron 8mg, b.i.d SL on D1-5 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AJCC 1-3 staged gastrointestinal cancer patient
- patient undergoing radiotherapy as treatment
- age 20 yr and higher
- ECOG 0-2
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ramosetronramosetron 0.1mg q.d. SL on D1-5 | Drug | RMS |
| ondansetronondansetron 8mg, b.i.d SL on D1-5 | Drug | ODS |
Primary outcome
complete response of RINV (no vomiting and no rescue medication)
Time frame: 4 weeks after medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2011.
- Background: PubMed 19060294Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ramosetron and ondansetron in people with Radiotherapy Induced Nausea and Vomiting, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response of RINV (no vomiting and no rescue medication) (time frame: 4 weeks after medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00971399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2011.