Modified early post-operative intraperitoneal chemotherapy for cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial aims to evaluate the feasibility of a modified early post-operative intraperitoneal chemotherapy (mEPIC) protocol following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis from colorectal and appendiceal tumors. The study will assess the completion rate of mEPIC compared to historical data on standard early post-operative intraperitoneal chemotherapy (EPIC) cohorts. Additionally, it will monitor the safety of the mEPIC protocol and identify any logistical challenges faced by nursing and oncology pharmacy teams during implementation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hôpital Maisonneuve-Rosemont
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Mikael Soucisse, MD, FRCSC — CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont
• Study coordinator: Mikael Soucisse, MD, FRCSC
• Email: mikael.lefebvre.soucisse@umontreal.ca
• Phone: 514-252-3400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.