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 range18 Years
SexALL
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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
✕. WHO performance status ≥ 2
✕. Any contraindication to chemotherapy and/or radiotherapy
✕. Any contraindication to repeated laparoscopy
What they're measuring
1
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