RecruitingPhase 2NCT05913674

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

Sponsor

Ciusss de L'Est de l'Île de Montréal

Enrollment

25 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Peritoneal Carcinomatosis Colorectal Cancer Metastatic Appendiceal Neoplasms

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a modified form of EPIC (early post-operative chemotherapy delivered directly into the abdomen) to treat cancer that has spread to the lining of the abdomen (peritoneal carcinomatosis) from colorectal or appendix tumors. **You may be eligible if...** - You are 18 or older - You have colorectal or appendix cancer that has spread to the abdominal lining (peritoneal carcinomatosis) - You have good general health (ECOG 0–1) - You are scheduled for or have recently had cytoreductive surgery (surgery to remove as much cancer as possible) **You may NOT be eligible if...** - Your cancer has spread to other distant organs beyond the abdomen - You have poor kidney or liver function - You are pregnant or breastfeeding - You have had previous abdominal chemotherapy (HIPEC or similar) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGModified 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.