Status:
UNKNOWN
Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
258 Patients enrolled
Trial Details
Trial ID
NCT01238094
Start Date
April 1 2010
End Date
May 1 2014
Last Update
June 14 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Samsung Medical Center
Seoul, South Korea