Normothermic Intraperitoneal Chemotherapy - Long Term in Peritoneal Metastases From Colorectal Cancer (NIPEC-OXA)
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- STATUS
- Recruiting
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- End date
- Jun 30, 2023
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- participants needed
- 20
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- sponsor
- Oslo University Hospital
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.
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:
- Intra-abdominal chemotherapy drug distribution 7-14 days after CRS and HIPEC and before the 4th NIPEC-OXA course
- Surgical complications after CRS, HIPEC and NIPEC-OXA until 3 months after the last NIPEC-OXA course
- Disease-free survival (DFS)
- 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
Details
| Condition | Colon cancer; rectal cancer, Colon Cancer Screening, Peritoneal Metastases, Colorectal Cancer |
|---|---|
| Treatment | Oxaliplatin |
| Clinical Study Identifier | NCT05056389 |
| Sponsor | Oslo University Hospital |
| Last Modified on | 9 October 2021 |
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