Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases

PHASE3CompletedINTERVENTIONAL
Enrollment

530

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

July 31, 2022

Study Completion Date

January 31, 2025

Conditions
Colorectal CancerLiver Metastases
Interventions
DRUG

FOLFOX/ FOLFIRI with bevacizumab

"FOLFIRI + bevacizumab Bevacizumab 5 mg/kg in 15-30 minutes i.v., followed by irinotecan 180 mg/m2 i.v. in 60 minutes together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by bolus 5-fluorouracil 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks~FOLFOX6 + bevacizumab Bevacizumab 5 mg/kg in 15-30 minutes i.v., followed by oxaliplatin 85 mg/m2 i.v. together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by bolus 5FU 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks"

DRUG

FOLFOXIRI with bevacizumab

FOLFOXIRI + bevacizumab Bevacizumab 5 mg/kg in 15-30 minutes i.v., followed by irinotecan 165 mg/m2 i.v. in 60 minutes, followed by oxaliplatin 85 mg/m2 i.v. together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by continuous infusion of 5-fluorouracil 3200 mg/m2 in 46 hours, every 2 weeks

DRUG

FOLFOX/ FOLFIRI with panitumumab

"FOLFIRI + panitumumab Panitumumab 6 mg/kg i.v. (1st dose in 60 minutes, if well tolerated subsequent doses in 30 minutes), followed by irinotecan 180 mg/m2 i.v. in 60 minutes together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by bolus 5-fluorouracil 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks~FOLFOX6 + panitumumab Panitumumab 6 mg/kg i.v. (1st dose in 60 minutes, if well tolerated subsequent doses in 30 minutes), followed by oxaliplatin 85 mg/m2 i.v. together with leucovorin 400 mg/m2 i.v. in 120 minutes, and bolus 5FU 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks"

Trial Locations (56)

Unknown

Universitair ziekenhuis Antwerpen, Antwerp

Flevoziekenhuis, Almere Stad

Gelre Ziekenhuis, Apeldoorn

Rijnstate ziekenhuis, Arnhem

Sint Jansdal Ziekenhuis, Harderwijk

Radboud UMC, Nijmegen

Streekziekenhuis Koningin Beatrix, Winterswijk

Atrium Medical Center, Heerlen

Maastricht UMC+, Maastricht

Laurentius Ziekenhuis, Roermond

Orbis Medical Center, Sittard

VieCuri Medisch Centrum, Venlo

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch

Bravis Ziekenhuis, Bergen op Zoom

Amphia Ziekenhuis, Breda

Elkerliek Ziekenhuis, Helmond

Bravis Ziekenhuis, Roosendaal

Sint Elisabeth Ziekenhuis, Tilburg

TweeSteden Ziekenhuis, Tilburg

Bernhoven, Uden

Maxima Medisch Centrum, loc. Veldhoven, Veldhoven

Medisch Centrum Alkmaar, Alkmaar

Amsterdam UMC, location VUMC, Amsterdam

Antoni van Leeuwenhoek, Amsterdam

BovenIJ Ziekenhuis, Amsterdam

OLVG, locatie Oost, Amsterdam

OLVG, locatie West, Amsterdam

Spaarne Gasthuis, Haarlem

Tergooi, Hilversum

Spaarne ziekenhuis, Hoofddorp

Waterlandziekenhuis, Purmerend

Zaans Medical Center, Zaandam

Deventer Ziekenhuis, Deventer

Medisch Spectrum Twente, Enschede

Ziekenhuisgroep Twente, Hengelo

Isala Klinieken, Zwolle

Ziekenhuis Nij Smellinghe, Drachten

Medisch Centrum Leeuwarden, loc. Zuid, Leeuwarden

Antonius Ziekenhuis, Sneek

Martini Ziekenhuis, Groningen

UMC Groningen, Groningen

Reinier de Graaf, Delft

Albert Schweitzer Ziekenhuis, Dordrecht

LUMC, Leiden

Erasmus MC, Rotterdam

Ikazia Ziekenhuis, Rotterdam

Maasstad Ziekenhuis, Rotterdam

Sint Franciscus Gasthuis, Rotterdam

Franciscus Vlietland, Schiedam

Hagaziekenhuis, The Hague

Medisch Centrum Haaglanden, Westeinde, The Hague

UMC Utrecht, Utrecht

Meander Medisch Centrum, Amersfoort

Sint Antonius Ziekenhuis, Nieuwegein

Admiraal de Ruyter ziekenhuis, Goes

1105AZ

Amsterdam UMC, location AMC, Amsterdam

All Listed Sponsors
lead

Dutch Colorectal Cancer Group

OTHER

NCT02162563 - Treatment Strategies in Colorectal Cancer Patients With Initially Unresectable Liver-only Metastases | Biotech Hunter | Biotech Hunter