Acronym

ORCHESTRA

Name of the study

A randomized multicenter clinical trial for patients with multi-ORgan, Colorectal cancer metastases comparing the combination of cHEmotherapy and maximal tumor debulking versuS chemoTheRapy Alone

Researchers and contact information

Principal Investigators:

Prof. dr. H.M.W. Verheul

henk.verheul@radboudumc.nl

Prof. dr. C. Verhoef

c.verhoef@erasmusmc.nl

 

Trial coordinator:

drs. Lotte Bakkerus

orchestra.onco@radboudumc.nl

Summary study

Colorectal cancer (CRC) is one of the leading causes of cancer death world-wide mostly as a consequence of metastatic disease. Currently, patients with unresectable liver or extrahepatic metastases of CRC receive systemic chemotherapy with or without monoclonal antibodies.New developments in local treatments, including surgical procedures, radiofrequency ablation (RFA), transarterial chemo-embolization using irinotecan drug-eluted beads (DEBIRI-TACE) and radiotherapy, have been suggested to further improve survival time when used for individual selected patients with limited disease. It is unknown to what extent these strategies improve survival compared to systemic chemotherapy because comparising studies of these treatment modalities have not been performed. The ORCHESTRA trial is a multicenter randomized controlled trial to study whether adding maximal tumor debulking by local treatment of metastases to combination chemotherapy will benefit survival of patients with multi-organ metastatic CRC.

Ultimately, 478 patients will be included. The primary objective of this study is to compare overall survival rates of patients with multi-organ CRC metastases randomized for treatment with combination chemotherapy or treatment with combination chemotherapy and additional maximal tumor debulking. Secondary objectives include progression free survival to determine the safety and efficacy of tumor debulking and to determine quality of life in the two study arms. If successful, this study may define a new standard of care for patients with metastatic CRC.

Intervention

 

Participating Centers

• Academisch Medisch Centrum, AMSTERDAM
• Albert Schweitzer Ziekenhuis, DORDRECHT
• Admiraal de Ruijterziekenhuis, VLISSINGEN
• Antoni van Leeuwenhoek ziekenhuis (NKI), AMSTERDAM
• Amphia Ziekenhuis, BREDA
• Bravis Ziekenhuis locatie Bergen op Zoom, BERGEN OP ZOOM/ ROOSENDAAL
• Deventer Ziekenhuis, DEVENTER
• Elisabeth-Tweesteden Ziekenhuis TILBURG
• Erasmus Medisch Centrum, ROTTERDAM
• Gelre ziekenhuizen, locatie Apeldoorn en Zutphen
• IJsselland Ziekenhuis, CAPELLE A/D IJSSEL
• Isala Klinieken, ZWOLLE
• Jeroen Bosch Ziekenhuis, DEN BOSCH
• Maasstad Ziekenhuis, ROTTERDAM
• Maxima Medisch Centrum, VELDHOVEN
• Medisch Centrum Leeuwarden, LEEUWARDEN
• Medisch Centrum Haaglanden, DEN HAAG
• Medisch Spectrum Twente
• Meander Medisch Centrum, AMERSFOORT
• Noordwest Ziekenhuisgroep, ALKMAAR
• OLVG locatie Oost, AMSTERDAM
• Radboud UMC, NIJMEGEN
• St. Antonius Ziekenhuis Nieuwegein, NIEUWEGEIN
• Sint Franciscus Gasthuis, ROTTERDAM
• VU Medisch Centrum, AMSTERDAM
• Westfriesgasthuis
• ZGT locatie Almelo, ALMELO
• Ziekenhuis Amstelland, AMSTELVEEN
• University Hospital Southampton NHS Foundation, Southampton, UK