Treatment of Malignant Peritoneal Mesothelioma (MESOTIP)

NCT03875144 | Suspended Phase 2 DMC

• 1 other identifier: PROICM 2019-03 MES
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peritoneal Mesothelioma; Peritoneal Carcinomatosis

Keywords

Peritoneal mesothelioma; PIPAC; Surgical oncology; Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• overall survival

  The overall survival is defined as the time from the date of randomization to the date of death from any cause

  from randomization of first patient until the database cut-off

Secondary Outcomes (5)

• Response to treatment using PFS

  week 10, week21,every 4 months during 2 years

• Adverse event

  during treatment

• Feasibility of compliance

  Week 21

• Conversion to resectability

  surgery

• Quality of life evaluation

  baseline, week10, week21, FU every 4 months during 2 years

Study Arms (2)

association of PIPAC and systemic chemotherapy

EXPERIMENTAL

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)

Procedure: PIPAC; Drug: Cisplatin; Drug: Pemetrexed

systemic chemotherapy alone

ACTIVE COMPARATOR

6 cycles of Cisplatin 75mg/m² + Pemetrexed 500mg/m²

Drug: Cisplatin; Drug: Pemetrexed

Interventions

PIPAC PROCEDURE

Pressurized IntraPeritoneal Aerosol Chemotherapy of Cisplatin 10.5mg/m² + Doxorubicin 2.1 mg/m² every 6 weeks

Also known as: Cisplatin, Doxorubicin

association of PIPAC and systemic chemotherapy

Cisplatin DRUG

standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²)

association of PIPAC and systemic chemotherapy; systemic chemotherapy alone

Pemetrexed DRUG

standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²)

association of PIPAC and systemic chemotherapy; systemic chemotherapy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• WHO performance status ≥ 2
• Any contraindication to chemotherapy and/or radiotherapy
• Any contraindication to repeated laparoscopy
• Symptomatic cardiac or coronary insufficiency
• Severe renal insufficiency
• Progressive active infection or any other severe medical condition
• Intestinal occlusion non responsive to medical treatment
• Other cancer treated within the last 2 years except in situ cervical carcinoma or basocellular/spinocellular carcinoma
• Pregnant or breast-feeding woman
• Previously operated patients where laparoscopy is not feasible
• Persons deprived of liberty or under guardianship or incapable of giving consent
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut réginal du Cancer de Montpellier

Montpellier, 34298, France

Location

Related Publications (7)

• Kim 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 BACKGROUND

• Boffetta 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 BACKGROUND

• Bossard 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 BACKGROUND

• Alexander 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 BACKGROUND

• Yan 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 BACKGROUND

• Baratti 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 BACKGROUND

• 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.

  PMID: 25124472 BACKGROUND

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Cisplatin; Doxorubicin; Pemetrexed

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Olivia SGARBURA, MD

  Institut régional du Cancer de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 14, 2019
• Study Start: September 10, 2020
• Primary Completion: December 16, 2024
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)