Pleurectomy/decortication and hypterthermic intrathoracic chemotherapy compared to pleurectomy/decortication in patients with malignant pleural mesothelioma

INTERVENTION: Trade Name: Cisplatin Product Name: Cisplatin Teva Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cisplatin CAS Number: 15663‐27‐1 Current Sponsor code: Cis Other descriptive name: CISPLATIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1mg/ml‐ CONDITION: malignant pleuramesothelioma ; MedDRA version: 16.1 Level: PT Classification code 10027407 Term: Mesothelioma malignant System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Malignant pleural mesothelioma is a yet uncurable disease, with a; median survival of 9 months after diagnosis. Treatment is usually; multimodulary, including operation, chemotherapy and radiation.; HITHOC (hyperthermic intrathrocic chemotherapy) with cisplatin and; doxorubicin is used to enhance lokal tumor control after pleurectomy; and decortication. In some patients, survival of 2 years can be achieved.; However, the chemotherapeutics can have severe lokal and systemic; side effects. No data exist to which extend hyperthermia and; chemotherapy add to the beneficial effect. The aim of this study is to compare the standard surgical procedure followed by HITHOC therapy to the standard surgery alone and thus identify the therapeutic; option of sufficient effectivity with reduced side effects. Disease‐free; and overall survival, therapy induced morbidities and quality of life will; be documented. Primary end point(s): overall survival Secondary Objective: not applicable Timepoint(s) of evaluation of this end point: 2 years after inclusion of the last patient SECONDARY OUTCOME: Secondary end point(s): disease free survival ; morbidiy ; quality of life Timepoint(s) of evaluation of this end point: every 3 months INCLUSION CRITERIA: Patients age = 80 years epithelioid pleural mesothelioma P3D is not possible or desired Ph. I‐II; Ph. III (T1‐T2 N1/N2 no LK‐bulks) Diagnosis by biopsy VATS + Biopsy ECOG performance status 0‐1 Creatinine <1.2 mg / dl, GFR> 60 ml / min no relevant KHK no other primary therapy signed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range