Adenocarcinoma of RectumPhase 2NCT02161822
Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
A Phase 2 study testing simvastatin in people with Adenocarcinoma of Rectum, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Statins are widely used as lipid-lowering agents to lower cardiovascular risk with a favorable safety profile. In our recent in vitro study, the addition of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adenocarcinoma of Rectum
- What is being tested?
- simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2014to Dec 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed adenocarcinoma of rectum
- AJCC/UICC clinical stages of cT3-4 or cN+
- age ≥ 20 years
- ECOG performance status 0-1
- No prior chemotherapy and radiotherapy
- Adequate major organ functions as following:
- Written informed consent
- Willing and able to comply the protocol
Who cannot join
- Prior statins therapy within 1-year from the date of study entry
- Uncontrolled or severe cardiovascular disease :
- New York Heart Association class III or IV heart disease Unstable angina or myocardial infarction within the past 6 months History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality.
- Past or current history (within the last 5 years prior to treatment start) of other malignancies except rectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)
- Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection
- Pregnant nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
- Patients with CPK > 5 X ULN at baseline
- Concomitant use with clarithromycin, erythromycin, itraconazole, ketoconazole, nefazodone, telithromycin, gemfibrozil, cyclosporine, danazol, amiodarone, verapamil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Phase II Study of Neoadjuvant Chemoradiotherapy With Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
Statins are widely used as lipid-lowering agents to lower cardiovascular risk with a favorable safety profile. In our recent in vitro study, the addition of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data). So we planned this study to investigate the synergistic effect of simvastatin combined with capecitabine and radiotherapy in locally advanced rectal cancer patients.
Read the detailed description
- Primary Objective: pathologic complete response rate
- Secondary Objectives:
- rate of sphincter-sparing surgical procedure
- rate of R0 resection
- disease-free survival
- overall survival
- pattern of failure
- safety and toxicity
- lipid lowering effect of simvastatin
- Conditions
- Adenocarcinoma of Rectum
- Being tested
- simvastatin
- Keywords
- locally advanced rectal cancer, neoadjuvant chemoradiation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
Also called Zocor tab
simvastatin 80mg qd for 5weeks
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | single arm : Simvastatin Receives: Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response rate
pathologic complete response ratewill be shown with 95% confidence intervals
Measured: average of 5 weeks
Secondary outcomes (7)
rate of sphincter-sparing surgical procedure
rate of sphincter-sparing surgical procedure
Measured: average of 5 weeks
rate of R0 resection
rate of R0 resection (N-60)
Measured: average of 5 weeks
disease-free survival
disease-free survival
Measured: assessed up to 60 months
overall survival
Time from randomization to death or last follow-up
Measured: assessed up to 60 months
pattern of failure
Sphincter preservation
Measured: assessed up to 60 months
safety and toxicity
Response rate according to RECIST 1,1 guideline will also be evaluated
Measured: assessed up to 6 months
lipid lowering effect of simvastatin
Total cholesterol, LDL-cholesterol records. (2weeks)
Measured: assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study start1 Oct 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of RectumStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ki Kang, Samsung Medical Center
- Investigators
- woon ki kang, professor, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161822
- Sponsor's protocol ID
- 2014-03-056
- Status last verified
- Mar 2020
- First submitted
- 30 May 2014
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Phase II Study of Neoadjuvant Chemoradiotherapy With Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
- ClinicalTrials.gov ID
- NCT02161822
- Acronym / sponsor ID
- 2014-03-056
- Conditions
- Adenocarcinoma of Rectum
- Keywords
- locally advanced rectal cancer, neoadjuvant chemoradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Jun 2014 (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.
Statins are widely used as lipid-lowering agents to lower cardiovascular risk with a favorable safety profile. In our recent in vitro study, the addition of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data). So we planned this study to investigate the synergistic effect of simvastatin combined with capecitabine and radiotherapy in locally advanced rectal cancer patients.
Detailed description
- Primary Objective: pathologic complete response rate
- Secondary Objectives:
- rate of sphincter-sparing surgical procedure
- rate of R0 resection
- disease-free survival
- overall survival
- pattern of failure
- safety and toxicity
- lipid lowering effect of simvastatin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: simvastatinsingle arm : Simvastatin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically-confirmed adenocarcinoma of rectum
- AJCC/UICC clinical stages of cT3-4 or cN+
- age ≥ 20 years
- ECOG performance status 0-1
- No prior chemotherapy and radiotherapy
Key exclusion criteria (8 listed)
- Prior statins therapy within 1-year from the date of study entry
- Uncontrolled or severe cardiovascular disease :
- New York Heart Association class III or IV heart disease Unstable angina or myocardial infarction within the past 6 months History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality.
- Past or current history (within the last 5 years prior to treatment start) of other malignancies except rectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)
- Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection
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 |
|---|---|---|
| simvastatinAlso: Zocor tabsimvastatin 80mg qd for 5weeks | Drug | Simvastatin |
Primary outcome
pathologic complete response rate
Time frame: average of 5 weeks
pathologic complete response ratewill be shown with 95% confidence intervals
7 secondary outcomes
rate of sphincter-sparing surgical procedure
Time frame: average of 5 weeks
rate of R0 resection
Time frame: average of 5 weeks
disease-free survival
Time frame: assessed up to 60 months
overall survival
Time frame: assessed up to 60 months
pattern of failure
Time frame: assessed up to 60 months
safety and toxicity
Time frame: assessed up to 6 months
lipid lowering effect of simvastatin
Time frame: assessed up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Adenocarcinoma of Rectum
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Colon Adenocarcinoma, Rectal Adenocarcinoma
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.
woon ki kang, professor 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 2 study testing simvastatin in people with Adenocarcinoma of Rectum, 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 8 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 25 Mar 2020. 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?
Results are not available in the source record.
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?
pathologic complete response rate (time frame: average of 5 weeks). 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 25 Mar 2020.