NCT04861558

Efficacy of Hyperthermic Intraperitoneal Chemotherapy

EFFIPEC - Efficacy of Hyperthermic Intraperitoneal Chemotherapy, Single-arm Phase I Study, Followed by an Open-label, Randomized, Controlled Registry-based Phase III Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 213 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

A dose titration study and a combined superiority registry-based open-label randomized control trial is planned to answer the trial objectives. The study will be registry-based to allow simpler and more comprehensive follow-up. Patients with colorectal cancer will be treated with cytoreductive surgery (CRS) together with either standard oxaliplatin HIPEC (the control for the efficacy study) or oxaliplatin/irinotecan HIPEC in combination with 5-FU 24-hour EPIC. The 5-FU will be administered postoperatively when the abdomen is completely sutured. The drug is divided equally into 2 injections of 200 ml each and injected through two abdominal drains that are clamped for 16 hours. For dose escalation, the titration groups (á 3 or 6 patients) are followed for 30 days postoperatively after which the Data Monitoring Committee (DMC) will determine whether or not to increase the 5-FU dose for the following group of patients. To study efficacy, randomization is performed intraoperatively. The patient is followed up postoperatively for a total of 3 years for the secondary endpoints which may be extended by the study committee to 5 years. Since the trial is registry based, the long-term follow-up does not require separate eCRF evaluations. These evaluations can be automatically retrieved from the registry - both recurrence data, quality of life, and morbidity data. Some specific eCRF evaluations will be integrated as a separate study part of the HIPEC registry, such as inclusion/exclusion criteria and adverse event reporting (including SUSAR reporting).

Detailed description

Not detailed description entered.

Conditions

• Colorectal Cancer
• Peritoneal Metastases

Interventions

Type	Name	Description
DRUG	5Fluorouracil	Injection of 250-850 mg/m2.
DRUG	Irinotecan	Injection of 360 mg/m2
DRUG	Oxaliplatin	Injection of 460 mg/m2

Timeline

• Start date: 2021-05-01
• Primary completion: 2025-12-01
• Completion: 2029-12-01
• First posted: 2021-04-27
• Last updated: 2025-05-30

Locations

5 sites across 2 countries: India, Sweden