SuspendedPhase 2

Treatment of Malignant Peritoneal Mesothelioma (MESOTIP)

Stopped: This decision was taken following the occurrence of three cases of serious and unexpected suspected adverse reactions (SUSARs), specifically febrile neutropenia, in participants assigned to the experimental arm combining PIPAC with systemic chemothe

France66 participantsStarted 2020-09-10

Plain-language summary

MESOTIP is a randomized trial evaluating the association of PIPAC and systemic chemotherapy versus systemic chemotherapy alone as 1st-line treatment of Malignant Peritoneal Mesothelioma In this study, patients in the experimental arm will be treated by 4 PIPAC (Cisplatine+Doxorubicine) alternating with 6 cycles of standard intravenous chemotherapy (Cisplatine+Pemetrexed). MESOTIP aim to show an improvement of the overall survival in the experimental arm.

Who can participate

Age range

18 Years

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.

Inclusion criteria

. Age ≥ 18 years
. PS (or WHO) \<2
. Histologically-confirmed diagnosis of peritoneal malignant mesothelioma
. No previous line of treatment (both medical and surgical oncologic treatments) for this disease
. Peritoneal Carcinomatosis Index (PCI)\>27 or at least 4 on the small bowel with serosal involvement contraindicating the cytoreductive surgery because of the impossibility to preserve a length \>=1.5 m of uninvolved small bowel
. Written and dated informed consent
. Affiliated to the French national social security system

Exclusion criteria

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

overall survival

Timeframe: from randomization of first patient until the database cut-off

Trial details

NCT IDNCT03875144

SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-16

View on ClinicalTrials.gov More Peritoneal Mesothelioma trials