Completed

PARF2008Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National

What is being tested

Percutaneous radiofrequency ablation (RFA)

Procedure

Who is being recruted

Over 18 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: November 2008

See protocol details

Summary

Principal SponsorInstitut Bergonié

Last updated: January 19, 2021

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2008

Actual date on which the first participant was enrolled.

Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it. The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis. This can be problematic in patients with respiratory failure for which surgical treatment has been challenged. Radiofrequency pulmonary developed as a therapeutic alternative, it has the advantage of being performed in a session with less toxicity in the lung parenchyma

NCT01841060

Principal SponsorInstitut Bergonié

Last updated: January 19, 2021

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate

ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP)

Expectancy greater than 6 months life

Histological diagnosis of non-small cell lung tumor established

PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV > = 2.5) at the lesion to be treated

Show More Criteria

9 exclusion criteria prevent from participating

Abnormal blood count platelets < 90000/mm3

Cons-indication to general anesthesia

Disorder of uncontrolled bleeding (TP < 50% TCA > 1.5 x control)

Location of the lesion does not allow achieving ablathermy under satisfactory conditions: lesion contiguous to the major anatomical structures of the mediastinum, hilar location (less than 1 cm from the hilum)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Percutaneous radiofrequency ablation (RFA)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

CHU de Bordeaux

Bordeaux, FranceOpen CHU de Bordeaux in Google Maps

Hôpital Cochin

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

Hôpital de Tenon

Paris, France

Completed9 Study Centers