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Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)

NCT05913674 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-14

No results posted yet for this study

Summary

The goal of this prospective phase II unicentric Canadian clinical trial is to clarify the feasibility of modified early post-operative intraperitoneal chemotherapy (mEPIC) following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in the clinical context of peritoneal carcinomatosis from colorectal and appendicular neoplasms.

The primary objective of this study is to confirm the feasibility of mEPIC by evaluating its completion rate compared to the one of historical standard early post-operative intraperitoneal chemotherapy (EPIC) cohorts. The secondary objectives of the study are to evaluate the safety of the mEPIC protocol by monitoring adverse events arising during the protocol and to assess logistical implementation barriers for the nursing and Oncology pharmacy teams, respectively.

Participants will undergo a modified schedule of EPIC (mEPIC) designed to maximize therapeutic benefit by exploiting the known pharmacokinetics and pharmacodynamics properties of fluorouracil (5-FU) while limiting the logistical issues of the standard protocol. mEPIC consists in shortening the original protocol from five to two days of postoperative intraperitoneal chemotherapy. Additionally, instead of solely administering a singular 5-FU bolus per 24 hours-period, mEPIC is based on the De Gramont intravenous regimen and consists of administering one intraperitoneal bolus of 5-FU (400 mg/m2) followed by a 24 hours-intraperitoneal infusion of 5-FU (1200 mg/m2) on postoperative days 1 and 2.

Conditions

  • Peritoneal Carcinomatosis
  • Appendiceal Neoplasms
  • Colorectal Cancer Metastatic

Interventions

DRUG

Modified early post-operative intraperitoneal chemotherapy (mEPIC)

On post-operative days 1 and 2, an abdominal reservoir is obtained by administering 1000 mL of plasmalyte with 50 mEq NaHCO3 via a Tenckhoff catheter. Participants will then receive an intraperitoneal fluorouracil bolus of 400 mg/m2 administered over 1 to 2 minutes followed by a continuous intraperitoneal fluorouracil infusion of 1200 mg/m2 over the next 24 hours. During the continuous intraperitoneal infusion of fluorouracil, 50 mg of folinic acid is administered intravenously. After completion of mEPIC day 1, the perfusate is drained out before starting mEPIC day 2.

Sponsors & Collaborators

  • Maisonneuve-Rosemont Hospital

    collaborator OTHER

  • Ciusss de L'Est de l'Île de Montréal

    lead OTHER

Principal Investigators

  • Mikael Soucisse, MD, FRCSC · CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-05-31
Completion
2028-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05913674 on ClinicalTrials.gov