Could a Two-Day chemo boost peritoneal cancer treatment?
NCT ID NCT05913674
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Canadian study tests a modified version of early post-operative chemotherapy given directly into the abdomen after surgery for peritoneal cancer from colorectal or appendix tumors. The standard treatment takes five days, but this new approach shortens it to two days using a continuous infusion of the drug fluorouracil. The trial aims to see if this shorter schedule is easier to complete and safer for patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fluorouracil (5-FU) and folinic acid given directly into the abdomen
- What this could lead to
- If successful, this could make post-surgery chemotherapy simpler and more practical for patients with peritoneal cancer, potentially improving treatment completion rates.
- What could go wrong
- This is a small, early-phase trial with only 25 participants, so results may not apply broadly. The modified regimen could still cause side effects or prove no better than the standard approach.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpital Maisonneuve-Rosemont
RECRUITINGMontreal, Quebec, H1T 2M4, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can Lab-Grown tumor models predict the best therapy for each patient?
- Can a smart drug home in on Hard-to-Treat cancers?
- Can a vaccine boost immunotherapy against a stubborn cancer?
- What does recovery really look like after aggressive peritoneal cancer surgery?