Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCiusss de L'Est de l'Île de Montréal
About this trial
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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Modified early post-operative intraperitoneal chemotherapy (mEPIC)
DrugOn post-operative days 1 and 2, an abdominal reservoir is obtained by administering 1000 mL of plasmalyte with 50 mEq NaHCO3 via a Tenckhoff catheter. Participants will then receive an intraperitoneal fluorouracil bolus of 400 mg/m2 administered over 1 to 2 minutes followed by a continuous intraperitoneal fluorouracil infusion of 1200 mg/m2 over the next 24 hours. During the continuous intraperitoneal infusion of fluorouracil, 50 mg of folinic acid is administered intravenously. After completion of mEPIC day 1, the perfusate is drained out before starting mEPIC day 2.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: mEPICExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of mEPIC
Evaluate mEPIC completion rate in patients with colorectal and appendicular cancer with peritoneal carcinomatosis treated with CRS and HIPEC and followed by mEPIC in a tertiary Canadian centre.
Time frame
2 days (assessed at the end of mEPIC protocol).Secondary outcomes
1
Safety of mEPIC
Evaluate the safety of the mEPIC protocol by monitoring adverse events arising during the protocol.
Time frame
Up to 3 weeks (assessed during the hospitalization following the participant's surgery).2
Satisfaction of care team
Assess satisfaction of care team including surgery and nursing teams regarding the implementation process of the mEPIC protocol. It is evaluated using a questionnaire form collecting comments from the care team about logistical barriers encountered during mEPIC protocol.
Time frame
2 days (assessed during mEPIC protocol)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ciusss de L'Est de l'Île de Montréal
Lead sponsor
Maisonneuve-Rosemont Hospital
Collaborator
Source ClinicalTrials.gov