Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration
NCT06281860 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2024-02-28
Summary
Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD).
Conditions
- Mesothelioma, Malignant
- Carcinoma, Non-Small-Cell Lung
- Carcinoma Breast Stage IV
- Ovarian Cancer
- Esophageal Cancer
- Gastric Cancer
Interventions
- DRUG
-
Cisplatine Teva®
PITHAC: Cisplatin (Cisplatine Teva®) at a dose between 7.5 and 70 mg/m2 of body surface at a temperature of 39±1°C
Sponsors & Collaborators
-
Dr Jean Yannis PERENTES
lead OTHER
Principal Investigators
-
Jean-Yannis Perentes · Centre Hospitalier Universitaire Vaudois
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-24
- Primary Completion
- 2025-12-01
- Completion
- 2026-02-01
Countries
- Switzerland
Study Locations
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