NCT05056389

Normothermic Intraperitoneal Chemotherapy - Long Term in Peritoneal Metastases From Colorectal Cancer (NIPEC-OXA)

Normothermic Intraperitoneal Chemotherapy - Long Term in Peritoneal Metastases From Colorectal Cancer - Feasibility Study (NIPEC-OXA)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Peritoneal Metastases
• Colo-rectal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Administration of oxaliplatin intraperitoneally

Timeline

• Start date: 2021-09-17
• Primary completion: 2023-03-31
• Completion: 2023-06-30
• First posted: 2021-09-24
• Last updated: 2021-09-30

Locations

1 site across 1 country: Norway