Treatment of Malignant Peritoneal Mesothelioma (MESOTIP)

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Treatments: Cisplatin; Doxorubicin; Liposomal doxorubicin; Pemetrexed

Criteria

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