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RECRUITING

NCT05913674

PHASE2

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

Sponsor: Ciusss de L'Est de l'Île de Montréal

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-01

Completion Date

2026-01

Last Updated

2024-08-21

Healthy Volunteers

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.

Inclusion Criteria: * Patient's age 18 years or older, both genders. * In good general health as evidenced by an ECOG score of 0 or 1. * Histological diagnosis of appendicular or colorectal tumors with peritoneal carcinomatosis, either synchronous (\< 12 months after primary diagnosis) or metachronous (\>12 months after the primary diagnosis) * Complete staging defined as: (1)Computed tomography (CT) scan of the chest, abdomen and pelvis. (2) Positron emission tomography (PET) scan when clinically appropriate. (3) Diagnostic laparoscopy reporting Peritoneal carcinomatosis index (PCI) +/- biopsy * Meets criteria for recommendation by combined multidisciplinary team and tumor board for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS+HIPEC) followed by mEPIC * Surgery must be performed within 4-6 weeks following the end of neoadjuvant therapy or 4-6 weeks following the patient's enrollment if no neoadjuvant therapy needed. * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the study duration * 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). Exclusion Criteria: Pre-cytoreductive surgery: * Other malignancies other than appendicular and colorectal neoplasms with peritoneal involvement * Inability to complete cytoreductive surgery (ECOG 2 or above) or any patient deemed unfit for surgery * Known allergic reaction or major toxicity to Fluorouracil * Contraindications to Fluorouracil, including history of coronary spasm and/or known dihydropyrimidine dehydrogenase deficiency * Pregnancy * Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon. * Any condition that would preclude the ability to deliver appropriate intraperitoneal (IP) therapy. Post-cytoreductive surgery: * Patient deemed not medically suitable to receive mEPIC protocol according to surgical team * Uncorrected coagulopathy and/or thrombocytopenia and/or neutropenia * Active infection * Hemodynamic and / or respiratory compromise * Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon. * Any condition that would preclude the ability to deliver appropriate IP therapy.

Locations (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada