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New treatment option for Peritoneal Carcinomatosis
Official title Technical Feasibility of Modified Early Post-Operative Intraperitoneal Chemotherapy (mEPIC)
ClinicalTrials.gov ID: NCT05913674
What this study is testing
What is Modified early post-operative intraperitoneal chemotherapy (mEPIC)?
Modified early post-operative intraperitoneal chemotherapy (mEPIC) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peritoneal carcinomatosis.
Also referred to as mEPIC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 the primary...
- Complete staging defined as: (1)Computed tomography (CT) scan of the chest, abdomen and pelvis. (2) Positron emission tomography (PET) scan when...
- Meets criteria for recommendation by combined multidisciplinary team and tumor board for cytoreductive surgery and hyperthermic intraperitoneal...
You likely can't join if
- 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
See the full eligibility 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 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...
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.