Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Liver Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Capecitabine

Bevacizumab

Oxaliplatin

Liver Extracts

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

immediate surgery of the primary colorectal tumor, no neoadjuvant therapy

neoadjuvant treatment with bevacizumab during 7 weeks prior to surgery of the colorectal primary

neoadjuvant treatment with CAPOX during 7 weeks prior to surgery of the colorectal primary

neoadjuvant treatment with bevacizumab and CAPOX during 7 weeks prior to surgery of the colorectal primary

no neo-adjuvant treatment, immediate surgery

immediate surgery (resection of primary colorectal tumor)

neo-adjuvant treatment with bevacizumab

neoadjuvant treatment with capecitabine and oxaliplatin

neo-adjuvant treatment with bevacizumab, capecitabine and oxaliplatin

Patricia Bottenberg, Ma ANP

Theo Ruers, PhD

Kees Punt, PhD

Wim Oyen, PhD

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

* Histological proven colorectal cancer without signs of bowel obstruction or bleeding
* Synchronous liver metastases
* WHO performance status 0-1

Treatment

* Arm A: immediate surgery of the primary colorectal tumor, no neoadjuvant therapy
* Arm B: neoadjuvant treatment with bevacizumab during 7 weeks prior to surgery of the colorectal primary
* Arm C: neoadjuvant treatment with CAPOX during 7 weeks prior to surgery of the colorectal primary
* Arm D: neoadjuvant treatment with bevacizumab and CAPOX during 7 weeks prior to surgery of the colorectal primary

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

Neo-adjuvant Therapy and the Effect on Synchronous Metastatic Growth

Accelerated Growth of Synchronous Colorectal Liver Metastases: Effects of Neo-adjuvant Therapy

Radboud University Medical Center

T.J.M Ruers, PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neo-adjuvant Therapy and the Effect on Synchronous Metastatic Growth	NCT00659022	Colorectal Neop... Liver Neoplasms	immediate surge... neo-adjuvant tr... neoadjuvant tre... neo-adjuvant tr...	18 Years - 80 Years	Radboud University Medical Center
Neo-adjuvant Therapy and the Effect on Synchronous Metastatic Growth	NCT00659022	Colorectal Neop... Liver Neoplasms	immediate surge... neo-adjuvant tr... neoadjuvant tre... neo-adjuvant tr...	18 Years - 80 Years	Radboud University Medical Center
Neo-adjuvant Therapy and the Effect on Synchronous Metastatic Growth	NCT00659022	Colorectal Neop... Liver Neoplasms	immediate surge... neo-adjuvant tr... neoadjuvant tre... neo-adjuvant tr...	18 Years - 80 Years	Radboud University Medical Center

Spots Global Cancer Trial Database for immediate surgery (resection of primary colorectal tumor)