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Could a Two-Day chemo boost peritoneal cancer treatment?

NCT ID NCT05913674

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hôpital Maisonneuve-Rosemont

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

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