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Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT02161822
Recruitment Status : Active, not recruiting
First Posted : June 12, 2014
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center

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of simvastatin to chemoradiotherapy with 5-FU showed synergistic anticancer effect in various colon cancer cells (unpublished data).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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of Rectum Drug: simvastatin Phase 2

Detailed Description:
  1. Primary Objective: pathologic complete response rate
  2. Secondary Objectives:

    1. rate of sphincter-sparing surgical procedure
    2. rate of R0 resection
    3. disease-free survival
    4. overall survival
    5. pattern of failure
    6. safety and toxicity
    7. lipid lowering effect of simvastatin

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Arm, Phase II Study of Neoadjuvant Chemoradiotherapy With Capecitabine Plus Simvastatin in Locally Advanced Rectal Cancer Patients
Actual Study Start Date : October 1, 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arm Intervention/treatment
Experimental: Simvastatin
single arm : Simvastatin
Drug: simvastatin
simvastatin 80mg qd for 5weeks
Other Name: Zocor tab




Primary Outcome Measures :
  1. pathologic complete response rate [ Time Frame: average of 5 weeks ]
    pathologic complete response ratewill be shown with 95% confidence intervals


Secondary Outcome Measures :
  1. rate of sphincter-sparing surgical procedure [ Time Frame: average of 5 weeks ]
    rate of sphincter-sparing surgical procedure

  2. rate of R0 resection [ Time Frame: average of 5 weeks ]
    rate of R0 resection (N-60)

  3. disease-free survival [ Time Frame: assessed up to 60 months ]
    disease-free survival

  4. overall survival [ Time Frame: assessed up to 60 months ]
    Time from randomization to death or last follow-up

  5. pattern of failure [ Time Frame: assessed up to 60 months ]
    Sphincter preservation

  6. safety and toxicity [ Time Frame: assessed up to 6 months ]
    Response rate according to RECIST 1,1 guideline will also be evaluated

  7. lipid lowering effect of simvastatin [ Time Frame: assessed up to 6 months ]
    Total cholesterol, LDL-cholesterol records. (2weeks)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161822


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: woon ki kang, professor Samsung Medical Center
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Responsible Party: Won Ki Kang, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02161822    
Other Study ID Numbers: 2014-03-056
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Won Ki Kang, Samsung Medical Center:
locally advanced rectal cancer, neoadjuvant chemoradiation
Additional relevant MeSH terms:
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Rectal Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors