| Added by | celine.gongora |
|---|---|
| Group name | EquipeCG |
| Item Type | Journal Article |
| Title | MESOTIP: Phase II multicenter randomized trial evaluating the association of PIPAC and systemic chemotherapy vs. systemic chemotherapy alone as 1st-line treatment of malignant peritoneal mesothelioma |
| Creator | Sgarbura et al. |
| Author | Olivia Sgarbura |
| Author | Sophie Gourgou |
| Author | Diego Tosi |
| Author | Naoual Bakrin |
| Author | Nabila Bouazza |
| Author | Stéphanie Delaine |
| Author | Marc Pocard |
| Author | François Quénet |
| Abstract | Background: Malignant peritoneal mesothelioma (MPM) is a rare tumoral disease characterized by the diffuse involvement of the peritoneal serosa. The standard frontline treatment of MPM is cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) unless the peritoneal disease is considered unresectable. For unresectable patients the standard frontline treatment is a combination of cisplatin and pemetrexed but the prognosis remains ominous with only 13 months of overall survival (OS). Methods: The proposed study is a multicenter randomized non-comparative study evaluating the association of Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) and systemic chemotherapy vs. systemic chemotherapy alone as first-line treatment of MPM. Patients will be randomized with a 2:1 ratio using a minimization technique. Sixty-six patients have to be enrolled. Stratification will be performed according to histology (epithelioid vs. sarcomatoid and biphasic), presence of extraperitoneal disease and center. Primary objective is OS and secondary objectives include progression-free survival (PFS), safety, compliance, feasibility, conversion to resectability, histological response to treatment and quality of life. Conclusions: We expect to show that intensification of the first line treatment with PIPAC for initially unresectable MPM patients increases OS. Trial registration: Prospective study. Clinicaltrials.gov: NCT03574493 EudraCT: 2019-001515-23. |
| Publication | Pleura and Peritoneum |
| Volume | 4 |
| Issue | 2 |
| Pages | 20190010 |
| Date | Jun 01, 2019 |
| Journal Abbr | Pleura Peritoneum |
| Language | eng |
| DOI | 10.1515/pp-2019-0010 |
| ISSN | 2364-768X |
| Short Title | MESOTIP |
| Library Catalog | PubMed |
| Extra | PMID: 31417958 PMCID: PMC6693480 |
| Tags | clinic, conversion to respectability, front line, malignant peritoneal mesothelioma, Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) |
| Date Added | 2019/10/10 - 10:50:44 |
| Date Modified | 2019/10/24 - 17:42:16 |
| Notes and Attachments | PubMed entry (Attachment) Texte intégral (Attachment) |
Institut de Recherche en Cancérologie de
