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: 14.1 Level: PT Classification code 10056558 Term: Peritoneal mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: CISPLATINO SANDOZ*EV 50MG 100M
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CISPLATIN
CAS Number: 15663-27-1
Concentration unit: mg/m2 milligram(s)/squar
Sponsors
ISTITUTO NAZIONALE PER LA CURA TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: progression free survival;Secondary Objective: overall survival toxicity identification of prognostic factors by biologic characterization of tumor regarding the expression of tyrosine kinase receptor expression and downstream effectors validation of osteopontin and mesothelin as potential diagnostic and prognostic tool;Primary end point(s): The primary endpoint of the study is to evaluated in patients affected by diffuse malignant peritoneal mesothelioma treated by cytoreductive surgery and hyperthermic intraperitoneal chemotherapy the progression free survival associated with personalized adjuvant systemic chemotherapy directed on the basis of in vitro chemosensitivity assay;Timepoint(s) of evaluation of this end point: the study consists of a accrual period of 3 years and 2 years of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): overall survival toxicity identification of prognostic factors by biologic characterization of tumor regarding the expression of tyrosine kinase receptor expression and downstream effectors validation of osteopontin and mesothelin as potential diagnostic and prognostic tool;Timepoint(s) of evaluation of this end point: OS: calculated from the begining of chemotherapy to the end of follow-up; toxicity: during the study; biological study: at the end of accrual; prognostic value of osteopontin and mesothelin: before the chemotherapy | — |
Countries
Italy
Contacts
Public ContactMarcello Deraco
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Outcome results
None listed