The Dutch Colorectal Cancer Group (DCCG) is a collaboration between medical disciplines that are relevant for the diagnosis and treatment of colorectal cancer (surgical oncology radiotherapy medical oncology pathology radiology gastroenterology).

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HEPATICA

A Randomized Two Arm Phase III Study in Patients Post Radical Resection of Liver Metastasis of Colorectal Cancer to investigate Bevacizumab in Combination With Capecitabine Plus Oxaliplatin (CAPOX) (q3w) as Adjuvant Chemotherapy versus CAPOX (q3w) alone as Adjuvant Treatment.

Summary

Arm A
CAPOX + bevacizumab after R0 resection
Arm B
CAPOX alone after R0 resection
Surgery
A R0 resection is defined as tumour negative resection margins at light microscopy, irrespective of the diameter of the resection margin.
Primary Endpoints
3-year disease free survival and overall survival
Principal Investigators
Dr. R. van Hillegersberg, Department of Surgery UMCUtrecht, The Netherlands
e-mail: r.vanhillegersberg@umcutrecht.nl,
Prof. Dr. E.E. Voest, Department of Medical Oncology, UMC Utrecht, The Netherlands
e-mail: E.E.Voest@umcutrecht.nl
Central Data Management
F.J.J. van Leeuwen, Trial Office IKO, Nijmegen, The Netherlands, F.vanLeeuwen@ONCO.umcn.nl

Introduction

Long-term survival of patients with metastatic colorectal cancer has only been achieved in
patients who could undergo radical surgical resection of metastases. Series of metastasectomy in liver metastases of colorectal cancer typically report a 5-year survival of 37%.
Improved imaging and surgical techniques have increased the number of patients receiving R0 resection for colorectal cancer. However, 60-80% of patients will develop local or distant recurrences after radical resection of colorectal liver metastasis. Thus, the majority of patients have the possobility to benefit from an adjuvant systemic treatment in order to reduce the chance of outgrowth of micrometastases. Several clinical studies have shown indications for a survival benefit. However, these studies are either underpowered or used only 5-FU as the systemic therapy. The FCCD 9002 Trial by Portier et al. shows, despite a suboptimal regimen with 5FU and leucovorin a disease free survival benefit of 12% for the treatment arm. The EPOC trial studied a neoadjuvant/adjuvant FOLFOX schedule versus no treatment in liver resection for colorectal liver metastases. Results of that trial were presented at ASCO in 2007 showing a significant disease free survival benefit only in the ‘as treated' group but not in the intention to treat analysis. In our opinion, a neoadjuvant approach is less attractive in patients with resectable metastases as surgery is postponed, morbidity is increased and the chance of missing metastases is enlarged after a good response. It is a logical step to add a targeted agent such as bevacizumab to improve the results of adjuvant therapy. The value of this strategy will be evaluated in our trial.

Study design

This study includes patients after R0 resection of liver metastasis without extra hepatic disease.

Study coordinator

Sander Schouten, MD, Phd Student
Surgical Oncology Research
Department of Surgery (G.04.228)
University Medical Centre Utrecht
P.O. Box 85500
3508 GA Utrecht
The Netherlands
tel. +31 88 755 5555 buzzer 4191
Mobile: 0031 624383968
Mail: s.b.schouten-2@umcutrecht.nl 
www.hepatica.nl

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The Dutch Colorectal Cancer Group (DCCG) is a collaboration between medical disciplines that are relevant for the diagnosis and treatment of colorectal cancer (surgical oncology radiotherapy medical oncology pathology radiology gastroenterology).