EUCTR2006-006072-38-SE
Active, not recruiting
Not Applicable
A Randomised Two Arm Phase III Study in Patients Post Radical Resection of Liver Metastasis of Colorectal Cancer to Investigate Bevacizumab (q3w) in Combination With Capecitabine Plus Elaoxantin (XELOX) (q3w) as Adjuvant Chemotherapy vs XELOX (q3w) alone as Adjuvant Treatment - Hepatica
the Dutch Colorectal Cancer Group0 sites620 target enrollmentSeptember 21, 2007
Conditionsiver metastatis of colorectal cancer.
DrugsAvastin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- iver metastatis of colorectal cancer.
- Sponsor
- the Dutch Colorectal Cancer Group
- Enrollment
- 620
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Signed written informed consent obtained prior to any study\-specific procedure.
- •2\.Age \= 18 years.
- •3\.Liver metastases radically resected (R0 resection)
- •4\.Study medication started \=4 and \= 8 weeks post liver surgery.
- •5\.Histologically confirmed liver metastasis of colorectal cancer after surgery.
- •6\.ECOG performance status 0 or 1 (Appendix 1\).
- •7\.Adequate hematology: neutrophils \=1\.5 x 109/L, platelets \=100 x 109/L, Hb \=5\.5 mmol/L, INR \= 1\.5, APTT \< 1\.5 X UNL.
- •8\.Adequate biochemistry: total bilirubin \=1\.5 UNL, ASAT and ALAT \=2\.5 x UNL, alkaline phosphatase \=2\.5 x UNL, serum creatinin \=1\.5 UNL.
- •9\.Urine dipstick \<2\+ for protein.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •1Extrahepatic metastatic disease.
- •2Adjuvant chemotherapy given \<6 months prior to detection of the liver metastases.
- •3Chemotherapy for metastatic disease.
- •4Prior non colorectal malignancies, except adequately treated basalioma of the skin or carcinoma in situ of the cervix.
- •5Bleeding diathesis or coagulation disorders or the need for full\-dose anticoagulation.
- •6Major surgical procedure \<4 weeks prior to start of study treatment.
- •7Females with a positive pregnancy test (within 14 days before treatment start).
- •8Lactating women.
- •9Fertile women (\<2 years after last menstruation) and women of childbearing potential not willing to use effective means of contraception.
- •10History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake.
Outcomes
Primary Outcomes
Not specified
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