Clinical trial · Interventional
Treatment of Malignant Peritoneal Mesothelioma (MESOTIP)
Phase II Multicenter Randomized Trial Evaluating the Association of PIPAC and Systemic Chemotherapy Versus Systemic Chemotherapy Alone as 1st-line Treatment of Malignant Peritoneal Mesothelioma
NCT03875144CI-TRIAL-00102749MESOTIPsuspendedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
| Peritoneal Mesothelioma | Peritoneal Mesothelial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| PIPAC | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- association of PIPAC and systemic chemotherapy
- description
- 4 PIPAC of Cisplatin 10.5mg/m² + Doxorubicin 2.1 mg/m² every 6 weeks alternating with standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²)
- interventionNames
- Procedure: PIPAC
- Drug: Cisplatin
- Drug: Pemetrexed
- type
- ACTIVE_COMPARATOR
- label
- systemic chemotherapy alone
- description
- 6 cycles of Cisplatin 75mg/m² + Pemetrexed 500mg/m²
- interventionNames
- Drug: Cisplatin
- Drug: Pemetrexed
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. PS (or WHO) \<2 3. Histologically-confirmed diagnosis of peritoneal malignant mesothelioma 4. No previous line of treatment (both medical and surgical oncologic treatments) for this disease 5. 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 6. Written and dated informed consent 7. Affiliated to the French national social security system Exclusion Criteria: 1. WHO performance status ≥ 2 2. Any contraindication to chemotherapy and/or radiotherapy 3. Any contraindication to repeated laparoscopy 4. Symptomatic cardiac or coronary insufficiency 5. Severe renal insufficiency 6. Progressive active infection or any other severe medical condition 7. Intestinal occlusion non responsive to medical treatment 8. Other cancer treated within the last 2 years except in situ cervical carcinoma or basocellular/spinocellular carcinoma 9. Pregnant or breast-feeding woman 10. Previously operated patients where laparoscopy is not feasible 11. Persons deprived of liberty or under guardianship or incapable of giving consent 12. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
References
Publications (7)
- BACKGROUNDKim J, Bhagwandin S, Labow DM. Malignant peritoneal mesothelioma: a review. Ann Transl Med. 2017 Jun;5(11):236. doi: 10.21037/atm.2017.03.96. PMID 28706904
- BACKGROUNDBoffetta P. Epidemiology of peritoneal mesothelioma: a review. Ann Oncol. 2007 Jun;18(6):985-90. doi: 10.1093/annonc/mdl345. Epub 2006 Oct 9. PMID 17030547
- BACKGROUNDBossard N, Velten M, Remontet L, Belot A, Maarouf N, Bouvier AM, Guizard AV, Tretarre B, Launoy G, Colonna M, Danzon A, Molinie F, Troussard X, Bourdon-Raverdy N, Carli PM, Jaffre A, Bessaguet C, Sauleau E, Schvartz C, Arveux P, Maynadie M, Grosclaude P, Esteve J, Faivre J. Survival of cancer patients in France: a population-based study from The Association of the French Cancer Registries (FRANCIM). Eur J Cancer. 2007 Jan;43(1):149-60. doi: 10.1016/j.ejca.2006.07.021. Epub 2006 Nov 3. PMID 17084622
- BACKGROUNDAlexander HR Jr, Li CY, Kennedy TJ. Current Management and Future Opportunities for Peritoneal Metastases: Peritoneal Mesothelioma. Ann Surg Oncol. 2018 Aug;25(8):2159-2164. doi: 10.1245/s10434-018-6337-5. Epub 2018 Feb 8. PMID 29423664
- BACKGROUNDYan TD, Deraco M, Baratti D, Kusamura S, Elias D, Glehen O, Gilly FN, Levine EA, Shen P, Mohamed F, Moran BJ, Morris DL, Chua TC, Piso P, Sugarbaker PH. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: multi-institutional experience. J Clin Oncol. 2009 Dec 20;27(36):6237-42. doi: 10.1200/JCO.2009.23.9640. Epub 2009 Nov 16. PMID 19917862
- BACKGROUNDBaratti D, Kusamura S, Cabras AD, Bertulli R, Hutanu I, Deraco M. Diffuse malignant peritoneal mesothelioma: long-term survival with complete cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC). Eur J Cancer. 2013 Oct;49(15):3140-8. doi: 10.1016/j.ejca.2013.05.027. Epub 2013 Jul 4. PMID 23831335
- Helm JH, Miura JT, Glenn JA, Marcus RK, Larrieux G, Jayakrishnan TT, Donahue AE, Gamblin TC, Turaga KK, Johnston FM. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: a systematic review and meta-analysis. Ann Surg Oncol. 2015 May;22(5):1686-93. doi: 10.1245/s10434-014-3978-x. Epub 2014 Aug 15.