Personalized adjuvant systemic chemotherapy of patients affected by diffuse malignant peritoneal mesothelioma using in vitro chemosensitivity assay

Phase 1

Active, not recruiting

Conditions: Patients affected by diffuse malignant peritoneal mesothelioma treated by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy, without any factor precluding the performance of systemic adjuvant chemotherapy
MedDRA version: 14.1Level: PTClassification code 10056558Term: Peritoneal mesothelioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-000382-20-IT

Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. histological diagnosis of DMPM done or confirmed by the Pathology department of our institute according to a diagnostic protocol that includes a morphological evaluation (H&E) and immunohistochemical study (positivity to at least one of the following markers: CK-5-6, calretinine, podoplanin, WT-1 and at least one negativity among the followings: CEA, Ber-Ep4 and claudin; 2. age = 18 years and < 71 years; 3. good performance status(ECOG<2); 4. patients that had undergone CRS + HIPEC with a complete cytoreduction; 5. surgical specimen obtained during the surgical treatment; 5. no metastatic disease; 6. signed informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. well differentiated papillary or multicystic mesothelioma; 2. other malignancies detected in the past 5 years excepting cutaneous basal cell carcinoma and in situ carcinoma of the uterine cervix; 3. previous systemic treatment of diffuse malignant peritoneal mesothelioma; 4. previous intraperitoneal chemotherapy; 5. non complete cytoreduction due to unresectable disease; 5. cardiac dysfunction with Ejection fraction <40%); 6. renal failure 7. hepatic insufficiency; 8. bone marrow insufficiency; 9. pulmonar dysfunction with FEV1 < 50% or a DLCO < 40% of normal value corrected by age; 10. viral or bacterial infection; 11. cognitive or consciousness dysfunction, drug or alcohol addiction or major psycosis.