Overview

Adjuvant HIPEC in High Risk Colon Cancer

Status:
Completed
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
This study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal oxaliplatin with concomitant i.v. 5-FU/LV, following a curative resection of a T4 or intra-abdominally perforated Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment. Hypothesis: The hypothesis is that adjuvant HIPEC preceding routine adjuvant systemic therapy using i.p. oxaliplatin with concomitant i.v. 5-FU/LV following a curative resection of a T4 or intra-abdominally perforated colon cancer reduces the development of peritoneal carcinomatosis in comparison to standard adjuvant systemic treatment alone.
Phase:
Phase 3
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators:
Dutch Health Care Insurance Board
ZonMw: The Netherlands Organisation for Health Research and Development
Treatments:
Capecitabine
Fluorouracil
Leucovorin
Oxaliplatin