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

Malignant Non-small Cell Neoplasm of Lung Stage Ia Clinical Trial

— PARF2008  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841060
• Other study ID #: IB2008-34
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2021
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

1. Patients over 18 years

2. Histological diagnosis of non-small cell lung tumor established.

3. Stage 1A tumors (lesions <= 3 cm, N0) report prepared by PET and CT

4. Surgical treatment of the lesion contrindiqué or refused by the patient,

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

6. Expectancy greater than 6 months life

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

8. Signed informed consent,

9. Patient affiliated to a social security scheme.

Exclusion criteria :

1. 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)

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

3. Abnormal blood count platelets <90000/mm3

4. Cons-indication to general anesthesia

5. Patient with a cardiac pacemaker if a review indicates treatment against ARF

6. pregnancy

7. Patient included in another clinical study

8. Unable to undergo medical monitoring test for geographical, social or psychological reasons,

9. Private patient freedom and major subject of a measure of legal protection or unable to consent.

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Non-small Cell Neoplasm of Lung Stage Ia

Intervention

Procedure:
• Percutaneous radiofrequency ablation (RFA)
Computed tomography (CT) was used to treat tumors under general anesthesia. Thoracic epidural anesthesia was administered in case of contraindication to general anesthesia mostly due to poor respiratory function. All patients were treated with the same multitine electrodes (LeVeen; Boston Scientific, Nattick. MA) measuring 3, 3.5, or 4 cm in diameter and at least 10 mm larger than the diameter of the target tumor. Multiple overlapping ablations were performed, when needed, in different parts of the tumor in order to cover the entire volume.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	Hôpital Cochin	Paris
France	Hôpital de Tenon	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	CH de Pau	Pau
France	CHU de Rennes	Rennes
France	CHU de Strasbourg	Strasbourg
France	CHU Rangueil-Larrey	Toulouse
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Palussière J, Chomy F, Savina M, Deschamps F, Gaubert JY, Renault A, Bonnefoy O, Laurent F, Meunier C, Bellera C, Mathoulin-Pelissier S, de Baere T. Radiofrequency ablation of stage IA non-small cell lung cancer in patients ineligible for surgery: results — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Tumor Control Rate 1 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.	one year after percutaneous radiofrequency ablation (RFA)
Secondary	Local Tumor Control Rate 3 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.	three years after percutaneous radiofrequency ablation (RFA)
Secondary	1-year Overall Survival (OS) Rate	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.	1 year after RFA
Secondary	3-year Overall Survival (OS) Rate	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.	3 years after RFA