Pre treatment with chemotherapy followed by surgery and removal of all intra-abdominal tumor and intra-peritoneal heated chemotherapy for peritoneal metastastasized colorectal cancer.

• Conditions: peritoneal carcinomatosis of colorectal origin; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-020787-37-NL
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-30
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Peritoneal carcinomatosis of colorectal origin diagnosed either at laparotomy or by malignant ascites on CT-scan. When ascites is diagnosed cytologic confirmation of peritoneal carcinomatosis is sufficient. At laparotomy either histologic or cytologic confirmation of peritoneal carcinomatosis is sufficient.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Age under 18
Previous chemotherapy
History of other malignancy
Advanced liver disease, Child-Pugh score>B
WHO performance status above 2.
Unable to give written informed consent.
Creatinine clearance below 30 ml/min
Liver or extra abdominal metastases
Neurotoxicity > grade 2 according CTC AE 3.0

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified