Colorectal CancerPhase 3NCT01238094
Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
A Phase 3 study testing Simvastatin in people with Colorectal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs XELIRI/FOLFIRI + placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to May 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented colorectal adenocarcinoma (previously failed to oxaliplatin)
- Age over 19 years old
- Performance status (ECOG scale): 0-2
- Measurable or evaluable disease
- Adequate organ functions
- Life expectancy ≥ 3 months
- No history of statin treatment within the last 12 months
- Patients should sign a written informed consent before study entry.
Who cannot join
- Tumor type other than adenocarcinoma
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, papillary thyroid carcinoma or prior malignancy treated more than 5 years ago without recurrence)
- Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
- Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Hyejin Jang, RN, 822-3410-6859, hyejin1217.jang@samsung.com
About this study
Official title: Placebo-controlled, Double-blinded Phase III Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs XELIRI/FOLFIRI + placebo.
Read the detailed description
To compare progression free survival of the standard second line chemotherapy (FOLFIRI, XELIRI) plus simvastatin in metastatic colorectal cancer patients. This trial is a placebo-controlled study.
- Conditions
- Colorectal Cancer
- Being tested
- Simvastatin
- Keywords
- colorectal cancer, simvastatin, second-line chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
simvastatin 40 mg qd daily until disease progression
| Study group | Role | What they receive |
|---|---|---|
| FOLFIRI or XELIRI/simvastatin | Experimental | FOLFIRI or XELIRI/simvastatin Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startApr 2010
- Primary completionNov 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Won Ki Kang, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238094
- Sponsor's protocol ID
- 2009-11-017
- Status last verified
- Jan 2012
- First submitted
- 22 Jun 2010
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled, Double-blinded Phase III Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01238094
- Acronym / sponsor ID
- 2009-11-017
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, simvastatin, second-line chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Nov 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 10 Nov 2010 (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 2nd line XELIRI/FOLFIRI + simvastatin vs XELIRI/FOLFIRI + placebo.
Detailed description
To compare progression free survival of the standard second line chemotherapy (FOLFIRI, XELIRI) plus simvastatin in metastatic colorectal cancer patients. This trial is a placebo-controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFIRI or XELIRI/simvastatin | Experimental | Drug: SimvastatinFOLFIRI or XELIRI/simvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically documented colorectal adenocarcinoma (previously failed to oxaliplatin)
- Age over 19 years old
- Performance status (ECOG scale): 0-2
- Measurable or evaluable disease
- Adequate organ functions
Key exclusion criteria (4 listed)
- Tumor type other than adenocarcinoma
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, papillary thyroid carcinoma or prior malignancy treated more than 5 years ago without recurrence)
- Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
- Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
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 |
|---|---|---|
| Simvastatinsimvastatin 40 mg qd daily until disease progression | Drug | FOLFIRI or XELIRI/simvastatin |
Primary outcome
Progression free survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Won Ki Kang, MD principal investigator
Samsung Medical Center
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 Simvastatin in people with Colorectal Cancer, run by Samsung 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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jun 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 12 months). 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 14 Jun 2013.