Fluorouracil for Colorectal cancer | Metastatic colorectal cancer

Inclusion criteria

• {"criterion_text":"- Provision of written informed consent prior to any study specific procedures.\n- ECOG Performance Status Score 0,1 or 2, alternatively Karnofsky 60-100.\n- Adequate kidney, liver, bone marrow function according to laboratory tests.\n- For females of childbearing potential, a negative pregnancy test must be documented.\n- ≥ 18 years old and <=78 years old.\n- Colorectal cancer with peritoneal metastases +/- liver metastases.\n- Concomitant resectable pulmonary metastases.\n- All patients deemed eligible for CRS and HIPEC according to clinical routine."}

Exclusion criteria

• {"criterion_text":"- Previous severe toxicity/allergic reactions to systemic chemotherapy agents oxaliplatin or irinotecan or 5-fluorouracil\n- Unable to tolerate intensified HIPEC treatment due to comorbidity.\n- Metastasis other than peritoneum or liver or lung (ie paraaortal lymph node or bone metastases)\n- Previous CRS or HIPEC.\n- Pregnant or lactating (nursing) women.\n- Active infections requiring antibiotics.\n- Active liver disease with positive serology for active hepatitis B, C, or known HIV\n- Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to and up to 4 weeks after study treatment.\n- Incomplete cytoreduction defined as completeness of cytoreduction score 2-3.\n- Histopathology of other origin than colorectal cancer."}

Primary endpoints

• {"endpoint_text":"- Phase I: Maximum tolerated dose of 5-FU 24-hour EPIC, assessed until 30 days post-treatment. Possible toxicity will be reported as Adverse Events.","definition_or_measurement_approach":"Assessed until 30 days post-treatment; toxicity recorded/reported as Adverse Events."}
• {"endpoint_text":"- Phase III: Local control rate within 24 months – Defined as peritoneal or liver recurrence. Retroperitoneal llg not included in this definition.","definition_or_measurement_approach":"Measured as local control (peritoneal or liver recurrence) within 24 months; retroperitoneal 'llg' not included per protocol text."}

Secondary endpoints

• {"endpoint_text":"- To evaluate the overall survival and RFS up to 5 years through the HIPEC registry.","definition_or_measurement_approach":"Overall survival and recurrence-free survival (RFS) captured via the HIPEC registry, up to 5 years."}
• {"endpoint_text":"- To evaluate postoperative complication rates within 30 days.","definition_or_measurement_approach":"Postoperative complication rates assessed within 30 days postoperatively."}
• {"endpoint_text":"- To evaluate the quality of life of patients up to 3 years after treatment.","definition_or_measurement_approach":"Quality of life measured up to 3 years after study treatment (assessment instruments not specified in the record)."}

Sweden

Earliest CTIS Part Ii Submission Date

06-08-2024

Latest Decision Or Authorization Date

13-04-2026

Processing Time Days

615

Number Of Sites

4

Number Of Participants

163

Primary sponsor

Full Name

Uppsala University

Organisation Type

Educational Institution

Country Of Registered Address

Sweden