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Phase II Study Comparing Normothermic Versus Hyperthermic Intraoperative Chemoperfusion With Oxaliplatin in Patients With Peritoneal Metastases From Appendiceal or Colon Cancer


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Peritoneal Carcinomatosis

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Trial Information

Phase II Study Comparing Normothermic Versus Hyperthermic Intraoperative Chemoperfusion With Oxaliplatin in Patients With Peritoneal Metastases From Appendiceal or Colon Cancer


Inclusion Criteria:



- Patients with peritoneal carcinomatosis from colorectal origin (including appendiceal
mucinous neoplasms and the pseudomyxoma syndromes) amenable for cytoreduction and
HIPEC.

Exclusion Criteria:

- No written informed consent

- Irresectable and/or metastatic disease found during surgery

- Known allergy to oxaliplatin

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Morbidity

Outcome Description:

Scoring of postoperative morbidity according to the Dindo-Clavien system

Outcome Time Frame:

Until discharge or within 30 days

Safety Issue:

Yes

Principal Investigator

Wim P Ceelen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ghent University Hospital

Authority:

Belgium: Ethics Committee

Study ID:

2012/237

NCT ID:

NCT01575730

Start Date:

June 2012

Completion Date:

July 2014

Related Keywords:

  • Peritoneal Carcinomatosis
  • Peritoneal carcinomatosis from colorectal or appendiceal origin
  • Fever
  • Carcinoma

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