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)
Conditions
Interventions
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: CI
Sponsors
Asklepios Fachkliniken München Gauting
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
Exclusion criteria: no signed informed consent inoperable Health does not allow the application of local chemotherapy and hyperthermia Cisplatin is contraindicated in patients: with a hypersensitivity to cisplatin, other platinum-containing drugs or any of the excipients with renal dysfunction (creatinine clearance <60ml/min) which are in a dehydrated state (used to prevent serious Impaired renal function before and after the application of a hydrogenation required) with myelosuppression with a hearing impairment with cisplatinbedingter neuropathy the silent in combination with yellow fever vaccine and prophylactic phenytoin inserted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: not applicable;Primary end point(s): overall survival;Timepoint(s) of evaluation of this end point: 2 years after inclusion of the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): disease free survival morbidiy quality of life;Timepoint(s) of evaluation of this end point: every 3 months | — |
Countries
Germany
Contacts
Public ContactKlinik für Thoraxchirurgie
Asklepios Fachkliniken München-Gauting
Outcome results
None listed