EFFIPEC – Efficacy of Hyperthermic Intraperitoneal Chemotherapy Single-arm Phase I study, followed by an open-label, randomized, controlled registry-based phase III trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516224-34-00

Acronym

EFFIPEC01

Enrollment

163

Registered

2024-08-16

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer

Brief summary

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., Phase III: Local control rate within 24 months – Defined as peritoneal or liver recurrence. Retroperitoneal llg not included in this definition.

Detailed description

To evaluate the overall survival and RFS up to 5 years through the HIPEC registry., To evaluate postoperative complication rates within 30 days., To evaluate the quality of life of patients up to 3 years after treatment.

Interventions

DRUGIRINOTECAN

DRUGFLUOROURACIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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., Phase III: Local control rate within 24 months – Defined as peritoneal or liver recurrence. Retroperitoneal llg not included in this definition.	—

Secondary

Measure	Time frame
To evaluate the overall survival and RFS up to 5 years through the HIPEC registry., To evaluate postoperative complication rates within 30 days., To evaluate the quality of life of patients up to 3 years after treatment.	—

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026