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Neo-adjuvant Therapy and the Effect on Synchronous Metastatic Growth

NCT00659022 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-09-12

No results posted yet for this study

Summary

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

Conditions

  • Colorectal Neoplasms
  • Liver Neoplasms

Interventions

PROCEDURE

immediate surgery (resection of primary colorectal tumor)

no neo-adjuvant treatment, immediate surgery

DRUG

neo-adjuvant treatment with bevacizumab

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

DRUG

neoadjuvant treatment with capecitabine and oxaliplatin

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

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

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Theo Ruers, PhD · The Netherlands Cancer Institute

  • Kees Punt, PhD · Radboud University Nijmegen Medical Center

  • Wim Oyen, PhD · Radboud University Nijmegen Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00659022 on ClinicalTrials.gov