drugset / Trial / NCT03875144

Treatment of Malignant Peritoneal Mesothelioma (MESOTIP)

NCT03875144 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-09-10
Primary completion
2024-12-16
Completion
2027-06

Outcome

Outcome not reported

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”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 10.5 mg/m2 Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous