NCT02161822

Brief 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of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data). So we planned this study to investigate the synergistic effect of simvastatin combined with capecitabine and radiotherapy in locally advanced rectal cancer patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 30, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

6.2 years

First QC Date

May 30, 2014

Last Update Submit

March 23, 2020

Conditions

Adenocarcinoma of Rectum

Keywords

locally advanced rectal cancer, neoadjuvant chemoradiation

Outcome Measures

Primary Outcomes (1)

  • pathologic complete response rate

    pathologic complete response ratewill be shown with 95% confidence intervals

    average of 5 weeks

Secondary Outcomes (7)

  • rate of sphincter-sparing surgical procedure

    average of 5 weeks

  • rate of R0 resection

    average of 5 weeks

  • disease-free survival

    assessed up to 60 months

  • overall survival

    assessed up to 60 months

  • pattern of failure

    assessed up to 60 months

  • +2 more secondary outcomes

Study Arms (1)

Simvastatin

EXPERIMENTAL

single arm : Simvastatin

Drug: simvastatin

Interventions

simvastatinDRUG

simvastatin 80mg qd for 5weeks

Also known as: Zocor tab
Simvastatin

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-720, South Korea

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • woon ki kang, professor

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Samsung Medical Center

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 12, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

KR(1)