Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration

NCT06281860 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-02-28

No results posted yet for this study

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

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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Entities

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 NCT06281860 on ClinicalTrials.gov