EUCTR2013-003830-34-DE
Active, not recruiting
Not Applicable
Pleurectomy/decortication and hypterthermic intrathoracic chemotherapy compared to pleurectomy/decortication in patients with malignant pleural mesothelioma - HITHOC
Asklepios Fachkliniken München Gauting0 sitesSeptember 25, 2013
Conditionsmalignant 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]
DrugsCisplatin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- malignant pleuramesothelioma
- Sponsor
- Asklepios Fachkliniken München Gauting
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<1\.2 mg / dl, GFR\> 60 ml / min
- •no relevant KHK
- •no other primary therapy
- •signed consent form
Exclusion Criteria
- •no signed informed consent
- •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
- •with myelosuppression
- •with a hearing impairment
Outcomes
Primary Outcomes
Not specified
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