Thoracic Mesothelioma: Surgery with or without subsequent lavage at high temperature with addition of chemotherapy
- Conditions
- malignant pleuramesotheliomaMedDRA version: 16.1Level: PTClassification code 10027407Term: Mesothelioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003830-34-DE
- Lead Sponsor
- Asklepios Fachkliniken München Gauting
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method