Colorectal Cancer | Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
Colorectal Cancer research study
What is the primary objective of this study?
The purpose of this study is to compare 2nd line XELIRI/FOLFIRI + simvastatin vs XELIRI/FOLFIRI + placebo.
Who is eligible to participate?
Inclusion Criteria: 1. Histologically documented colorectal adenocarcinoma (previously failed to oxaliplatin) 2. Age over 19 years old 3. Performance status (ECOG scale): 0-2 4. Measurable or evaluable disease 5. Adequate organ functions 6. Life expectancy ≥ 3 months 7. No history of statin treatment within the last 12 months 8. Patients should sign a written informed consent before study entry. Exclusion Criteria: 1. Tumor type other than adenocarcinoma 2. 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) 3. Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment. 4. 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Simvastatinsimvastatin 40 mg qd daily until disease progression
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
FOLFIRI or XELIRI/simvastatinFOLFIRI or XELIRI/simvastatin
Start Date: April 2010
Completed Date: May 2014
Phase: Phase 3
Primary Outcome: Progression free survival
Study sponsors, principal investigator, and references
Principal Investigator: Won Ki Kang, MD
Lead Sponsor: Samsung Medical Center