Advanced Colorectal CancerPhase 2NCT01929421
A Phase II Trial of Salvage Treatment With Gemcitabine and S-1 Combination in Patients With Heavily Treated Advanced Colorectal Cancer.
A Phase 2 study testing Gemcitabine/S-1 in people with Advanced Colorectal Cancer, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination in metastatic colorectal cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Gemcitabine/S-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Dec 2014
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non resectable colorectal adenocarcinoma.
- disease progression during or within 6months after treatment with irinotecan and oxaliplatin contaning regimens.
- estimated life expectancy of more than 3 months.
- ECOG status 2 or lower
Who cannot join
- other tumor type than adenoarcinoma.
- presence or history of CNS metastasis.
- evidence of gastrointestinal bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination in metastatic colorectal cancer
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Gemcitabine/S-1
- Keywords
- colorectal cancer, gemcitabine, S-1
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine/S-1Drug
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/ s-1 | Experimental | Not described Receives: Drug: Gemcitabine/S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 1year
Secondary outcomes (2)
overall survival
Measured: 1year
number of participants with adverse events
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startDec 2009
- Primary completionJun 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Kyung Ahn, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929421
- Sponsor's protocol ID
- 2009-GIRBA-2075
- Status last verified
- May 2018
- First submitted
- 19 Aug 2013
- Last updated
- 11 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Salvage Treatment With Gemcitabine and S-1 Combination in Patients With Heavily Treated Advanced Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT01929421
- Acronym / sponsor ID
- 2009-GIRBA-2075
- Conditions
- Advanced Colorectal Cancer
- Keywords
- colorectal cancer, gemcitabine, S-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Aug 2013 (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.
To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination in metastatic colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/ s-1 | Experimental | Drug: Gemcitabine/S-1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non resectable colorectal adenocarcinoma.
- disease progression during or within 6months after treatment with irinotecan and oxaliplatin contaning regimens.
- estimated life expectancy of more than 3 months.
- ECOG status 2 or lower
Key exclusion criteria (3 listed)
- other tumor type than adenoarcinoma.
- presence or history of CNS metastasis.
- evidence of gastrointestinal bleeding.
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 |
|---|---|---|
| Gemcitabine/S-1 | Drug | Gemcitabine/ s-1 |
Primary outcome
Response rate
Time frame: 1year
2 secondary outcomes
overall survival
Time frame: 1year
number of participants with adverse events
Time frame: 1year
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 11 May 2018.
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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 2 study testing Gemcitabine/S-1 in people with Advanced Colorectal Cancer, run by Gachon University Gil Medical Center 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 3 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 11 May 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Response rate (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2018.