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

Phase 2

Recruiting

• Conditions: Peritoneal Carcinomatosis; Appendiceal Neoplasms; Colorectal Cancer Metastatic

• Registration Number: NCT05913674
• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-5-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Inclusion Criteria:<br><br> - Patient's age 18 years or older, both genders.<br><br> - In good general health as evidenced by an ECOG score of 0 or 1.<br><br> - Histological diagnosis of appendicular or colorectal tumors with peritoneal<br> carcinomatosis, either synchronous (< 12 months after primary diagnosis) or<br> metachronous (>12 months after the primary diagnosis)<br><br> - Complete staging defined as: (1)Computed tomography (CT) scan of the chest, abdomen<br> and pelvis. (2) Positron emission tomography (PET) scan when clinically appropriate.<br> (3) Diagnostic laparoscopy reporting Peritoneal carcinomatosis index (PCI) +/-<br> biopsy<br><br> - Meets criteria for recommendation by combined multidisciplinary team and tumor board<br> for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS+HIPEC)<br> followed by mEPIC<br><br> - Surgery must be performed within 4-6 weeks following the end of neoadjuvant therapy<br> or 4-6 weeks following the patient's enrollment if no neoadjuvant therapy needed.<br><br> - Provision of signed and dated informed consent form<br><br> - Stated willingness to comply with all study procedures and availability for the<br> study duration<br><br> - Hematology: Absolute neutrophil count (ANC) = 1,500/ µL; Platelets > 75,000/ µL.<br><br> - Adequate Renal function Creatinine <1.5 x the upper limit of normal (ULN) or<br> calculated creatinine clearance of = 50ml/min.<br><br> - Adequate Hepatic function: Bilirubin less than 1.5mg/dL; (except in patients with<br> Gilbert's Syndrome, who must have a total bilirubin less than 3.0mg/dL).<br><br>Exclusion Criteria:<br><br>Pre-cytoreductive surgery:<br><br> - Other malignancies other than appendicular and colorectal neoplasms with peritoneal<br> involvement<br><br> - Inability to complete cytoreductive surgery (ECOG 2 or above) or any patient deemed<br> unfit for surgery<br><br> - Known allergic reaction or major toxicity to Fluorouracil<br><br> - Contraindications to Fluorouracil, including history of coronary spasm and/or known<br> dihydropyrimidine dehydrogenase deficiency<br><br> - Pregnancy<br><br> - Evidence of extensive intraperitoneal adhesions at the time of surgery which<br> prohibits intraperitoneal therapy, as determined by the operating surgeon.<br><br> - Any condition that would preclude the ability to deliver appropriate intraperitoneal<br> (IP) therapy.<br><br>Post-cytoreductive surgery:<br><br> - Patient deemed not medically suitable to receive mEPIC protocol according to<br> surgical team<br><br> - Uncorrected coagulopathy and/or thrombocytopenia and/or neutropenia<br><br> - Active infection<br><br> - Hemodynamic and / or respiratory compromise<br><br> - Evidence of extensive intraperitoneal adhesions at the time of surgery which<br> prohibits intraperitoneal therapy, as determined by the operating surgeon.<br><br> - Any condition that would preclude the ability to deliver appropriate IP therapy.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of mEPIC

Secondary Outcome Measures

Name	Time	Method
Safety of mEPIC;Satisfaction of care team