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CAIRO 4

Acronym

CAIRO 4

Name of the study

The role of surgery of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastases of colorectal cancer, a multicenter randomized phase III study.


Researchers and contact information

Principal Investigators:

Dr. M. Koopman
m.koopman-6@umcutrecht.nl

Prof. Dr. J.H.W. de Wilt
hans.dewilt@radboudumc.nl


Trial coordinator:

Drs. Karlijn van Rooijen
k.l.vanrooijen-4@umcutrecht.nl
06-55240325

Summary study

The clinical benefit of resection of the primary tumour in patients with synchronous unresectable colorectal cancer metastases is not known. In literature, several retrospective studies comparing large groups of patients with or without resection of the primary tumour suggest an improved survival when the primary tumour is resected. All these studies are biased in patient selection and there are no prospective randomized studies on this topic. A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour during chemotherapy treatment or during later stages of the disease. An argument against resection is that palliative systemic treatment is being postponed. A recent analysis of the CAIRO and CAIRO2 data showed that metastatic colorectal cancer patients who had a resection of the primary tumour prior to study entry, had an improved survival compared to patients without a resection of the primary tumour. However, these patients were selected after the primary tumour was resected and therefore these results are not corrected for surgical morbidity and mortality. We here propose a randomized trial in order to demonstrate that resection of the primary tumour does improve overall survival. Patients who are not participating for any reason (i.e. not willing to participate, not eligible for any reason, etc.) can be registered after informed consent in order to use their clinical data/outcome to extend the study database with extra information on this relevant topic. Inclusion of patients is performed in hospital in the Netherlands and Denmark.

Intervention

Arm A

First-line fluoropyrimidine-based chemotherapy with bevacizumab initiated within 4 weeks of randomization, followed by salvage therapy upon progression at the discretion of the local investigator. Surgery of primary tumour will be performed only when indicated by local signs or symptoms.

Arm B

Surgery within 4 weeks of randomization followed by fluoropyrimidine-based chemotherapy with bevacizumab until progression or unacceptable toxicity, followed by salvage therapy upon progression at the discretion of the local investigator.

Participating centers

  • Academisch Medisch Centrum, AMSTERDAM
  • Albert Schweitzer Ziekenhuis, DORDRECHT
  • Amphia Ziekenhuis, BREDA
  • Antonius Ziekenhuis Sneek, SNEEK
  • Bernhoven, OSS
  • Bravis Ziekenhuis locatie Bergen op Zoom, BERGEN OP ZOOM
  • Bravis Ziekenhuis locatie Roosendaal, ROOSENDAAL
  • Bronovo Ziekenhuis, DEN HAAG
  • Catharina Ziekenhuis, EINDHOVEN
  • Deventer Ziekenhuis, DEVENTER
  • Diakonessenhuis Utrecht-Zeist, UTRECHT-ZEIST
  • Elisabeth-Tweesteden Ziekenhuis TILBURG
  • Elkerliek Ziekenhuis, HELMOND
  • Erasmus Medisch Centrum, ROTTERDAM
  • Flevo Ziekenhuis, ALMERE
  • Franciscus Gasthuis & Vlietland locatie Sint Franciscus Gasthuis, ROTTERDAM
  • Franciscus Gasthuis & Vlietland locatie Vlietland Ziekenhuis, SCHIEDAM
  • Gelre Ziekenhuizen, APELDOORN
  • Gelre Ziekenhuizen, ZUTPHEN
  • Gemini Ziekenhuis, DEN HELDER
  • Groene Hart Ziekenhuis, GOUDA
  • HagaZiekenhuis, DEN HAAG
  • IJsselland Ziekenhuis, CAPELLE A/D IJSSEL
  • Ikazia Ziekenhuis, ROTTERDAM
  • Isala Diaconessenhuis, STEENWIJK
  • Isala Klinieken, ZWOLLE
  • Jeroen Bosch Ziekenhuis, DEN BOSCH
  • Laurentius Ziekenhuis, ROERMOND
  • Maasstad Ziekenhuis, ROTTERDAM
  • Maastricht UMC+, MAASTRICHT
  • Martini Ziekenhuis, GRONINGEN
  • Maxima Medisch Centrum, VELDHOVEN
  • Medisch Centrum Leeuwarden, LEEUWARDEN
  • Medisch Centrum Alkmaar, ALKMAAR
  • Medisch Centrum Haaglanden, DEN HAAG
  • Meander Medisch Centrum, AMERSFOORT
  • Nij Smellinghe, DRACHTEN
  • OLVG locatie Oost, AMSTERDAM
  • OLVG locatie West, AMSTERDAM
  • Radboud UMC, NIJMEGEN
  • Rode Kruis Ziekenhuis, BEVERWIJK
  • Slingeland Ziekenhuis, DOETINCHEM
  • Spaarne Gasthuis locatie Hoofddorp, HOOFDDORP
  • Spaarne Gasthuis locatie Zuid, HAARLEM
  • St. Anna Ziekenhuis, GELDROP
  • St. Antonius Ziekenhuis Nieuwegein, NIEUWEGEIN
  • St. Jansdal, HARDERWIJK
  • St. Jans Gasthuis, WEERT
  • St. Lucas Andreas Ziekenhuis, AMSTERDAM
  • Tergooi Ziekenhuizen, HILVERSUM
  • Tergooi Ziekenhuizen, BLARICUM
  • UMC Groningen, GRONINGEN
  • UMC Utrecht, UTRECHT
  • Van Weel Bethesda Ziekenhuis, DIRKSLAND
  • VieCuri locatie Venlo, VENLO
  • VU Medisch Centrum, AMSTERDAM
  • Waterlandziekenhuis, PURMEREND
  • Westfriesgasthuis, HOORN
  • Wilhelmina Ziekenhuis, ASSEN
  • Zaans Medisch Centrum, ZAANDAM
  • ZGT locatie Almelo, ALMELO
  • Ziekenhuis Amstelland, AMSTELVEEN
  • Ziekenhuis Rivierenland, TIEL


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