Adjuvant HIPEC in High Risk Colon Cancer

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• age between 18 and 75 years

• Intention to start routine adjuvant systemic therapy

• adequate clinical condition to undergo simultaneous HIPEC or re- laparoscopy or re-laparotomy with HIPEC within either 10 days or between week 5-8 from --primary resection

• written informed consent

• white blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3

• no bleeding diathesis or coagulopathy

• normal creatinine or creatinine clearance of at least 50 ml/min

Exclusion Criteria:

• postoperative complications that interfere with adjuvant HIPEC within 8 weeks (i.e. persisting intra-abdominal abscess, significant fascial dehiscence, enteric fistula)

• no intention to start routine adjuvant systemic therapy

• liver and/or lung metastases

• pregnant or lactating women

• unstable or uncompensated respiratory or cardiac disease

• serious active infections

• other concurrent chemotherapy

• hypersensitivity to fluorouracil, folinic acid or another substance of leucovorin or oxaliplatin

• stomatitis, ulceration in the mouth or gastrointestinal tract.

• severe diarrhea

• severe hepatic and / or renal dysfunction.

• plasma bilirubin concentrations greater than 85 μmol/l.

• pernicious anemia or other anaemias due to vitamin B12 deficiency.

• peripheral sensory neuropathy with functional impairment.