Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, simvastatin, second-line chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FOLFIRI or XELIRI/simvastatin
Arm Description
FOLFIRI or XELIRI/simvastatin
Outcomes
Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01238094
Brief Title
Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
Official Title
Placebo-controlled, Double-blinded Phase III Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, simvastatin, second-line chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
258 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOLFIRI or XELIRI/simvastatin
Arm Type
Experimental
Arm Description
FOLFIRI or XELIRI/simvastatin
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Intervention Description
simvastatin 40 mg qd daily until disease progression
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Ki Kang, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyejin Jang, RN
Phone
822-3410-6859
Email
hyejin1217.jang@samsung.com
12. IPD Sharing Statement
Learn more about this trial
Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
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