Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer
NCT ID: NCT01238094
Last Updated: 2013-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
258 participants
INTERVENTIONAL
2010-04-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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FOLFIRI or XELIRI/simvastatin
FOLFIRI or XELIRI/simvastatin
Simvastatin
simvastatin 40 mg qd daily until disease progression
Interventions
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Simvastatin
simvastatin 40 mg qd daily until disease progression
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Principal Investigators
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Won Ki Kang, MD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Facility Contacts
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Other Identifiers
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2009-11-017
Identifier Type: -
Identifier Source: org_study_id
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