CompletedPhase 2

PIPAC for Peritoneal Metastases of Colorectal Cancer

Netherlands20 participantsStarted 2017-10-01

Plain-language summary

This is multicentre, open-label, single-arm phase II study that investigates the feasibility, safety, tolerability, preliminary efficacy, costs, and pharmacokinetics or repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC-OX) as a palliative monotherapy for patients with isolated unresectable colorectal peritoneal metastases.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Eligible patients are adults who have: * a World Health Organisation (WHO) performance status of ≤1; * histological or cytological proof of PM of a colorectal or appendiceal carcinoma; * unresectable disease determined by abdominal computed tomography (CT) and a diagnostic laparoscopy or laparotomy; * adequate organ functions (haemoglobin ≥5.0 mmol/L, neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L, serum creatinine \<1.5 x ULN, creatinine clearance ≥30 ml/min, and liver transaminases \<5 x ULN); * no symptoms of gastrointestinal obstruction; * no radiological evidence of systemic metastases; * no contraindications for oxaliplatin or 5-fluorouracil/leucovorin; * no contraindications for a laparoscopy; * no previous PIPAC-procedures. Enrolled patients are excluded from the analyses in case they did not receive a first ePIPAC-OX, e.g.: * due to systemic metastases on baseline thoracoabdominal CT, or; * due to non-access during first ePIPAC-OX, or; * due to resectable disease during first ePIPAC-OX. Importantly, enrolment is allowed for patients with an unresected primary tumour (if asymptomatic) and for patients in various lines of palliative treatment, including patients who refuse, have not had, or do not qualify for first-line palliative systemic therapy. All potentially eligible patients are discussed by a multidisciplinary team. Enrolled patients are informed about the potential consequences of postponing or discontinuing standard palliative treatment by a medical onc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Major toxicity

Timeframe: Expected (in case of three ePIPAC-OX): 16 weeks

Trial details

NCT IDNCT03246321

SponsorKoen Rovers

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-01

View on ClinicalTrials.gov More Colorectal Neoplasms trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.