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

Launched by CIUSSS DE L'EST DE L'ÎLE DE MONTRÉAL · Jun 12, 2023

Keywords

ClinConnect Summary

This clinical trial, called the mEPIC study, is looking at a new way to give chemotherapy after surgery for patients with certain types of cancer, specifically those with peritoneal carcinomatosis related to colorectal or appendiceal tumors. The goal is to see if this modified treatment method is feasible and safe compared to standard chemotherapy protocols. Participants will receive a shorter course of chemotherapy over two days instead of the usual five days, which is designed to be more effective while reducing complications.

To be eligible for the trial, participants need to be at least 18 years old, in good overall health, and diagnosed with specific types of cancer that have spread within the abdominal cavity. They must also be able to undergo surgery as part of their treatment. If enrolled, participants can expect to receive specific doses of chemotherapy on the first two days after their surgery, while the study team monitors their health and any possible side effects. The trial is currently recruiting participants, and those interested should discuss it with their healthcare team to see if they qualify.

Gender

ALL

Eligibility criteria

• 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.