Feasibility study regarding 20 Patients with peritoneal metastases from colorectal cancer treated with cytoreductive surgery and HIPEC and subsequently with 4 courses of normothermic intraperitoneal chemotherapy - long term (NIPEC-OXA) with oxaliplatin.
Primary endpoint: to determine if the administration of additional i.p. chemotherapy for a period of 9 weeks after completed CRS and HIPEC is a safe procedure to be used in the future in a formal randomised trial. The toxicity of the chemotherapy given through i.p. during NIPEC-OXA courses will be analysed throughout the entire treatment period and a subsequent 3-month follow-up period. Secondary endpoints: 1. Intra-abdominal chemotherapy drug distribution 7-14 days after CRS and HIPEC and before the 4th NIPEC-OXA course 2. Surgical complications after CRS, HIPEC and NIPEC-OXA until 3 months after the last NIPEC-OXA course 3. Disease-free survival (DFS) 4. Overall survival (OS) Exploratory endpoint: quality of life Estimated date of first patient enrolled: 3rd quarter of 2021 Anticipated recruitment period: 1,5 years Estimated treatment completion date of last patient: 1st quarter of 2023 Expected treatment duration per patient: 9 weeks Expected follow-up period per patient: 3 months after the last NIPEC-OXA procedure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Administration of oxaliplatin intraperitoneally
The Norwegian, Radium Hospital, Oslo University Hospital
Oslo, Norway
RECRUITINGNumber of Participants with Adverse Events after Intraperitoneal Chemotherapy Administration (NIPEC-OXA)
Common Terminology Criteria for Adverse Events v. 5
Time frame: Throughout the entire treatment period, including a 3-month follow-up
Number of Participants with Surgical Complications after CRS, HIPEC and NIPEC-OXA
Clavien-Dindo classification
Time frame: Throughout the entire treatment period, including a 3-month follow-up
Number of Participants with Optimal, Suboptimal and Missing Fluid Distribution in the Abdomen Injected Through 2 I.P. Catheters
CT scans with intraperitoneal contrast
Time frame: 7-14 days after CRS and HIPEC and before the 4th NIPEC-OXA course
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