Efficacy of Hyperthermic Intraperitoneal Chemotherapy
Status:
Recruiting
Trial end date:
2029-12-01
Target enrollment:
Participant gender:
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 (รก 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).