Colorectal Cancer
Conditions
Keywords
colorectal cancer, simvastatin, second-line chemotherapy
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.
Interventions
DRUGSimvastatin
simvastatin 40 mg qd daily until disease progression
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | 12 months |
Countries
South Korea
Outcome results
None listed