Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Irinotecan

Chlorotrianisene

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Topoisomerase I Inhibitors

Enzyme Inhibitors

XELOX or FOLFOX regimen and maximal tumor debulking including Surgery, radiofrequency ablation (RFA), transarterial chemo-embolization using irinotecan drug-eluted beads ((DEBIRI)-TACE) or stereotactic body radiation therapy (SBRT).

XELOX regimen according to standard procedures

FOLFOX regimen according to standard procedures

Surgery

radiofrequency ablation (RFA)

transarterial chemo-embolization using irinotecan drug-eluted beads ((DEBIRI-)TACE)

stereotactic body radiation therapy (SBRT)

may be added to both regimens according to standard procedures

at baseline (diagnostic or study) biopsy and after 3 or 4 cycles an optional tumor biopsy

tumor biopsy

H.M.W. Verheul, MD PhD

Lotte Bakkerus, MD

MP Hendriks, Dr

R Hoekstra, R

J.M. Dodewaard

AA van Zweeden, Drs

K.S. Versteeg, MD, PhD

C.M.I. Grootscholten

H. Meulenbeld

O. Loosveld, Dr

JFM Pruijt, Dr

HH Helgason, Dr

H Torrenga, Dr

M Trajkovic, MD

G Vreugdenhil, Dr

L.J.M. Mekenkamp

M. Vleugel

M Polee, Dr

M Los, Dr

HMW Verheul, MD PhD

F. Terheggen, Dr.

F. Terheggen

C. Verhoef, MD PhD

D. Mathijssen, Dr

Vermaas

B.C.M. Haberkorn, Dr

L Beerepoot, Dr

van Halteren

S. Bakker

JWB de Groot, Dr

J. Bridgewater

J.N. Primrose

The purpose of this study is to compare overall survival rates of colorectal cancer patients with multi-organ metastases with an indication for first line systemic treatment randomized for treatment with combination chemotherapy or treatment with combination chemotherapy and additional maximal tumor debulking including surgical tumor resection, RFA, (DEBIRI-)TACE and SBRT, depending on best clinical judgement according to a standardized treatment algorithm. Our hypothesis is that maximal tumor debulking in addition to systemic treatment with chemotherapy and biologicals will provide an improvement in progression free and overall survival in this patient group.

Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases

A Randomized Multicenter Clinical Trial for Patient With Multi-organ, Colorectal Cancer Metastases Comparing the Combination of Chemotherapy and Maximal Tumor Debulking Versus Chemotherapy Alone.

Erasmus Medical Center

Radboud University Medical Center

Spots Global Cancer Trial Database for folfox regimen according to standard procedures