Tests a shortened early chemotherapy schedule after surgery for abdominal cancer spread
Tests a shorter post-surgery chemotherapy schedule in adults with colorectal cancer spread to the abdomen.
Key facts
- Who runs it
- Ciusss de L'Est de l'Île de Montréal
- Where
- Montreal, CanadaSee the site
- Trial code
- Registry title
- Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 25 people, planned
- Started
- 1 May 2026
- Expected to end
- Sept 2028
- Type of study
- Interventional
- Treatments tested
- Modified early post-operative intraperitoneal chemotherapy (mEPIC)
- Record updated
- 14 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colorectal or appendix tumours that have spread to the lining of the belly (peritoneum), who are planned for cytoreductive surgery and heated chemotherapy in the belly, followed by a short course of 5-FU chemotherapy given into the belly.
- Age
- 18 years or older
- Sex
- All genders can join.
- Disease stage
- Appendix or colorectal tumour with spread to the peritoneum (peritoneal carcinomatosis), found at diagnosis or later; full staging with scans and a diagnostic laparoscopy is needed.
- Earlier treatment
- Surgery must take place within 4-6 weeks after the end of neoadjuvant therapy, or within 4-6 weeks after enrolment if no neoadjuvant therapy is needed.
- Biomarker or test result
- Blood counts, kidney function and liver function must be adequate: neutrophils at least 1,500/μL, platelets above 75,000/μL, creatinine below 1.5 x the upper limit of normal or creatinine clearance of at least 50 ml/min, bilirubin below 1.5 mg/dL (below 3.0 mg/dL with Gilbert's syndrome).
Main reasons for not taking part
- Other cancer types with peritoneal involvement
- ECOG score of 2 or above, or not fit enough for surgery
- Allergy to fluorouracil, or a condition that rules out it, such as coronary spasm or DPD deficiency
- Pregnancy
- Extensive adhesions in the belly, active infection, or a condition that stops chemotherapy being given into the belly
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Pre-cytoreductive surgery:
- Inability to complete cytoreductive surgery (ECOG 2 or above) or any patient deemed unfit for surgery
- Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon
- Patient deemed not medically suitable to receive mEPIC protocol according to surgical team
- Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon
- Other malignancies other than appendicular and colorectal neoplasms with peritoneal involvement
- Known allergic reaction or major toxicity to Fluorouracil
- Contraindications to Fluorouracil, including history of coronary spasm and/or known dihydropyrimidine dehydrogenase deficiency
- Any condition that would preclude the ability to deliver appropriate intraperitoneal (IP) therapy; Post-cytoreductive surgery:
- Active infection
- Any condition that would preclude the ability to deliver appropriate IP therapy
- Pregnancy
- Uncorrected coagulopathy and/or thrombocytopenia and/or neutropenia
- Hemodynamic and / or respiratory compromise
Where in Canada
- Hôpital Maisonneuve-RosemontMontreal, CanadaContact: Mikael Soucisse, MD, FRCSCTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- mEPICTreatment being tested
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.
Treatment: Modified early post-operative intraperitoneal chemotherapy (mEPIC)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)
- Plain-language title
- Tests a shortened early chemotherapy schedule after surgery for abdominal cancer spreadGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 14 May 2026