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Anti-metabolites
mEPIC for Peritoneal Cancer
Phase 2
Recruiting
Led By Mikael Soucisse, MD, FRCSC
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 weeks (assessed during the hospitalization following the participant's surgery).
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a modified EPIC to maximize therapeutic benefit & limit logistical issues of standard EPIC protocol.
Who is the study for?
Adults with peritoneal tumors from appendiceal or colorectal cancer, who are in good health and have a low ECOG score (0-1), indicating they can perform daily activities without significant restrictions. They must have completed necessary imaging studies, possibly received neoadjuvant therapy, and be able to undergo surgery followed by mEPIC. Exclusions include allergies to Fluorouracil, other cancers, conditions preventing IP therapy, pregnancy, hemodynamic/respiratory compromise post-surgery.
What is being tested?
The trial is testing the feasibility of a modified chemotherapy regimen called mEPIC after cytoreductive surgery and HIPEC for patients with peritoneal carcinomatosis from colorectal or appendicular tumors. It aims to simplify treatment by reducing it to two days using fluorouracil bolus plus infusion based on De Gramont regimen.
What are the potential side effects?
Potential side effects may include those commonly associated with chemotherapy such as nausea, vomiting, fatigue, risk of infection due to lowered blood counts (neutropenia), potential kidney or liver function issues. Specific reactions related to Fluorouracil could also occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 weeks (assessed during the hospitalization following the participant's surgery).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 weeks (assessed during the hospitalization following the participant's surgery).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of mEPIC
Secondary study objectives
Safety of mEPIC
Satisfaction of care team
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: mEPICExperimental Treatment1 Intervention
Adults (male and female) with a diagnosis of appendicular or colorectal cancer with peritoneal carcinomatosis will undergo mEPIC on post-operative days 1 and 2 following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.
Find a Location
Who is running the clinical trial?
Maisonneuve-Rosemont HospitalOTHER
101 Previous Clinical Trials
38,302 Total Patients Enrolled
Ciusss de L'Est de l'Île de MontréalLead Sponsor
78 Previous Clinical Trials
6,390 Total Patients Enrolled
Mikael Soucisse, MD, FRCSCPrincipal InvestigatorCIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to remove as much of the cancer as possible.I do not have uncontrolled bleeding disorders or low blood platelet or white cell counts.I am scheduled for surgery to reduce my tumor size.I currently have an infection.I have cancer, but it's not in my appendix or colon with spread to the lining of my abdomen.My surgery is scheduled 4-6 weeks after my last treatment or after joining if I didn't need prior treatment.My cancer started in the appendix or colon and has spread to the lining of my abdomen.I am not fit for surgery due to my physical condition.I have no conditions that prevent me from receiving treatments directly into my abdomen.My surgical team has determined I can't undergo the mEPIC treatment.I have had a full body scan and, if needed, a PET scan and laparoscopy to check the extent of my cancer.My surgeon found extensive scar tissue in my abdomen that prevents certain treatments.A team of doctors agrees I should have surgery and heated chemo in my abdomen.I am 18 years old or older.My liver functions well, with bilirubin levels below the required threshold.My kidney function is within the normal range.I am in good health and can carry out all my usual activities without help.I cannot take Fluorouracil due to heart issues or a specific enzyme deficiency.I have issues with my blood flow or breathing.
Research Study Groups:
This trial has the following groups:- Group 1: mEPIC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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