Adjuvant HIPEC in High Risk Colon Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

204

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

September 30, 2018

Study Completion Date

June 1, 2019

Conditions
Colorectal NeoplasmsPeritoneal Neoplasms
Interventions
PROCEDURE

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.

DRUG

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.

PROCEDURE

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.

Trial Locations (9)

1105 AZ

Academic Medical Center, Amsterdam

Unknown

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

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

Dutch Health Care Insurance Board

OTHER

lead

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

NCT02231086 - Adjuvant HIPEC in High Risk Colon Cancer | Biotech Hunter | Biotech Hunter