Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive

Not Applicable

Completed

• Conditions: Malignant Non-small Cell Neoplasm of Lung Stage Ia
• Interventions: Procedure: Percutaneous radiofrequency ablation (RFA)

• Registration Number: NCT01841060
• Lead Sponsor: Institut Bergonié

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-26
• Results First Submitted: 2020-12-08
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-12
• Last Update Submitted: 2021-01-12
• Results First Posted: 2021-01-19
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiofrequency ablathermy	Percutaneous radiofrequency ablation (RFA)	Percutaneous radiofrequency ablation (RFA)

Primary Outcome Measures

Name	Time	Method
Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)	one year after percutaneous radiofrequency ablation (RFA)	local control is defined as the absence of progression of the ablated site. rate is defined as the number of alive patient without local progression divided by the number of patients alive at one year.

Secondary Outcome Measures

Name	Time	Method
3-year Overall Survival (OS) Rate	3 years after RFA	OS was defined as the time from RFA treatment to death, whatever the cause. If the patient was still alive at the end of study or lost to follow-up, the patient was censored at the date of last news.
Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA)	three years after percutaneous radiofrequency ablation (RFA)	local control is defined as the absence of progression of the ablated site. rate is defined as the number of alive patient without local progression divided by the number of patients alive at thee years.
1-year Overall Survival (OS) Rate	1 year after RFA	OS was defined as the time from RFA treatment to death, whatever the cause. If the patient was still alive at the end of study or lost to follow-up, the patient was censored at the date of last news. 1-year overall survival rate was estimated using the Kaplan-Meier estimator.

Trial Locations

Locations (9)

Hôpital Cochin; 🇫🇷 Paris, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Hôpital de Tenon; 🇫🇷 Paris, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

CH de Pau; 🇫🇷 Pau, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU Rangueil-Larrey; 🇫🇷 Toulouse, France

CHU de Strasbourg; 🇫🇷 Strasbourg, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France