OncoMatch/Clinical Trials/NCT05913674
Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)
Is NCT05913674 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Modified early post-operative intraperitoneal chemotherapy (mEPIC) for peritoneal carcinomatosis.
Treatment: Modified early post-operative intraperitoneal chemotherapy (mEPIC) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Colorectal Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500/μL; Platelets > 75,000/μL
Kidney function
Creatinine <1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50ml/min
Liver function
Bilirubin less than 1.5mg/dL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0mg/dL)
Hematology: Absolute neutrophil count (ANC) ≥ 1,500/ μL; Platelets > 75,000/ μL. Adequate Renal function Creatinine <1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50ml/min. Adequate Hepatic function: Bilirubin less than 1.5mg/dL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0mg/dL).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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