Clinical trial NCT01841060: Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive
Official title: Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Non-small Cell Neoplasm of Lung Stage Ia
Keywords: Malignant Non-small Cell Neoplasm of Lung
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2013-04-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)
timeFrame: one year after percutaneous radiofrequency ablation (RFA)
Secondary outcomes:
measure: Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA)
timeFrame: three years after percutaneous radiofrequency ablation (RFA)
measure: 1-year Overall Survival (OS) Rate
timeFrame: 1 year after RFA
measure: 3-year Overall Survival (OS) Rate
timeFrame: 3 years after RFA
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital de Tenon
city: Pau
country: France
facility: CH de Pau
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU Rangueil-Larrey
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Institut Bergonié
name: Jean PALUSSIERE, MD
role: STUDY_CHAIR
References:
citation: Palussiere 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 of a prospective multicenter phase II trial. J Cardiothorac Surg. 2018 Aug 24;13(1):91. doi: 10.1186/s13019-018-0773-y.