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Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma

NCT01644994 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2021-09-29

No results posted yet for this study

Summary

The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication or extrapleural pneumonectomy in a phase I and II study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model (phase I), and confirmation of safety and efficacy in phase II with the maximum tolerated dose in phase I.

Conditions

  • Malignant Pleural Mesothelioma

Interventions

COMBINATION_PRODUCT

intracavitary cisplatin-fibrin

single dose, local intracavitary application of cisplatin-fibrin after pleurectomy/decortication

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • Swiss Accident Insurance Fund SUVA

    collaborator UNKNOWN

  • University of Zurich

    lead OTHER

Principal Investigators

  • Isabelle Opitz, Professor MD · University Hospital Zurich, Division of Thoracic Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2019-12-31
Completion
2021-08-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01644994 on ClinicalTrials.gov