204
Participants
Start Date
March 31, 2015
Primary Completion Date
September 30, 2018
Study Completion Date
June 1, 2019
Adjuvant HIPEC (open/laparoscopic)
Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis fluid at a flow rate of 1-2l/min and an inflow temperature of 42-43˚C. Before the beginning of HIPEC, 5-fluorouracil 400 mg/m2 and leucovorin 20 mg/m2 will be administered intravenously to potentiate oxaliplatin activity. Oxaliplatin (460 mg/m2) is added to the perfusate after attaining at least 42 degrees inflow temperature with a total of 30 minutes perfusion time.
Standard adjuvant systemic chemotherapy
Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.
Diagnostic laparoscopy
Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms.
Academic Medical Center, Amsterdam
Antoni van Leeuwenhoek hospital, Amsterdam
Free University Medical Center, Amsterdam
Catharina hospital, Eindhoven
University Medical Centre Groningen, Groningen
Antonius hospital, Nieuwegein
Radboud University Medical Center, Nijmegen
Erasmus Medical Center, Rotterdam
University Medical Center Utrecht, Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Dutch Health Care Insurance Board
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER