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Sponsored by: |
Radboud University |
Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00659022 |
Study Hypothesis
• As well as in animal models as in patients with colorectal cancer resection of the primary tumor resulted in increase in vascular density, metabolism and secondary tumor growth of the distant metastases. These data strongly suggest an inhibitory effect of the primary tumor on the outgrowth of its metastases.
In this study we investigate whether pre-operative treatment with the anti-angiogenic agent bevacizumab and/or chemotherapy before resection of the primary colorectal tumor shifts the balance between angiogenic and anti-angiogenic factors in favor of the anti-angiogenic factors and results in reduced growth of the liver metastases.
Eligibility
Treatment
Primary endpoint Difference in response of liver metastases to resection of the primary tumor between the experimental groups and the control group, as determined by histopathological scoring of vascular density, apoptotic and mitotic index and by measurement of the metabolic activity of liver metastases by FDG-PET and SUV measurements.
Secondary endpoints Toxicity of neo-adjuvant treatment Complications of surgery
Condition | Intervention | Phase |
Colorectal Neoplasms Liver Neoplasms |
Procedure: immediate surgery (resection of primary colorectal tumor) Drug: neo-adjuvant treatment with bevacizumab Drug: neoadjuvant treatment with capecitabine and oxaliplatin Drug: neo-adjuvant treatment with bevacizumab, capecitabine and oxaliplatin |
Phase II |
MedlinePlus related topics: | Cancer Colorectal Cancer Liver Cancer |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Accelerated Growth of Synchronous Colorectal Liver Metastases: Effects of Neo-Adjuvant Therapy |
Estimated Enrollment: | 60 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Active Comparator
immediate surgery of the primary colorectal tumor, no neoadjuvant therapy
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Procedure: immediate surgery (resection of primary colorectal tumor)
no neo-adjuvant treatment, immediate surgery
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B: Experimental
neoadjuvant treatment with bevacizumab during 7 weeks prior to surgery of the colorectal primary
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Drug: neo-adjuvant treatment with bevacizumab
neoadjuvant treatment with bevacizumab during 7 weeks prior to surgery of the colorectal primary
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C: Experimental
neoadjuvant treatment with CAPOX during 7 weeks prior to surgery of the colorectal primary
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Drug: neoadjuvant treatment with capecitabine and oxaliplatin
neoadjuvant treatment with CAPOX during 7 weeks prior to surgery of the colorectal primary
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D: Experimental
neoadjuvant treatment with bevacizumab and CAPOX during 7 weeks prior to surgery of the colorectal primary
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Drug: neo-adjuvant treatment with bevacizumab, capecitabine and oxaliplatin
neoadjuvant treatment with bevacizumab and CAPOX during 7 weeks prior to surgery of the colorectal primary
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marian Scheer, MD | +31-24-3613956 | m.scheer@chir.umcn.nl |
Contact: Theo Ruers, PhD | +31-20-5122538 | t.ruers@nki.nl |
Netherlands | |||||
The Netherlands Cancer Institute/ Antoni van Leeuwenhoek Hospital | Recruiting | ||||
Amsterdam, Netherlands, 1066 CX | |||||
Contact: Theo Ruers, PhD +31-20-5122538 t.ruers@nki.nl | |||||
Radboud University Nijmegen Medical Center | Recruiting | ||||
Nijmegen, Netherlands, 6500 HB | |||||
Contact: Kees Punt, PhD +31-24-3610353 C.Punt@onco.umcn.nl |
Radboud University |
Principal Investigator: | Theo Ruers, PhD | The Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital Amsterdam |
Principal Investigator: | Kees Punt, PhD | Radboud University Nijmegen Medical Center |
Principal Investigator: | Wim Oyen, PhD | Radboud University Nijmegen Medical Center |
Responsible Party: | The Netherlands Cancer Institute/ Antoni van Leeuwenhoek Hospital Amsterdam ( T.J.M Ruers, PhD ) |
Study ID Numbers: | SILENT |
First Received: | April 3, 2008 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00659022 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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