Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive (PARF2008)

Institut Bergonié

Status: Completed

Conditions: Malignant Non-small Cell Neoplasm of Lung Stage Ia

Treatments: Procedure: Percutaneous radiofrequency ablation (RFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01841060

IB2008-34

Details and patient eligibility

About

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.

Full 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

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Radiofrequency ablathermy

Experimental group

Description:

Percutaneous radiofrequency ablation (RFA)

Treatment:

Procedure: Percutaneous radiofrequency ablation (RFA)