Status:
ACTIVE_NOT_RECRUITING
Treatment of Malignant Peritoneal Mesothelioma (MESOTIP)
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Peritoneal Mesothelioma
Peritoneal Carcinomatosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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,...
Detailed Description
Malignant peritoneal mesothelioma (MPM) is a rare tumoral disease characterized by the diffuse involvement of the peritoneal serosa. The incidence of all mesotheliomas is estimated quite differently i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03875144
Start Date
August 14 2020
End Date
September 1 2028
Last Update
February 12 2025
Active Locations (1)
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1
Institut réginal du Cancer de Montpellier
Montpellier, France, 34298