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Placebo-controlled, Double-blinded Phase III Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

Placebo-controlled, Double-blinded Phase III Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Won Ki Kang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

2009-11-017

NCT ID:

NCT01238094

Start Date:

April 2010

Completion Date:

May 2014

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • simvastatin
  • second-line chemotherapy
  • Colorectal Neoplasms

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