Status:
COMPLETED
Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive
Lead Sponsor:
Institut Bergonié
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Malignant Non-small Cell Neoplasm of Lung Stage Ia
Eligibility:
All Genders
18+ years
Phase:
NA
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 su...
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 s...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Patients over 18 years
- Histological diagnosis of non-small cell lung tumor established.
- Stage 1A tumors (lesions \<= 3 cm, N0) report prepared by PET and CT
- Surgical treatment of the lesion contrindiqué or refused by the patient,
- ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP)
- Expectancy greater than 6 months life
- PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV\> = 2.5) at the lesion to be treated,
- Signed informed consent,
- Patient affiliated to a social security scheme.
- Exclusion criteria :
- 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)
- Disorder of uncontrolled bleeding (TP \<50% TCA\> 1.5 x control).
- Abnormal blood count platelets \<90000/mm3
- Cons-indication to general anesthesia
- Patient with a cardiac pacemaker if a review indicates treatment against ARF
- pregnancy
- Patient included in another clinical study
- Unable to undergo medical monitoring test for geographical, social or psychological reasons,
- Private patient freedom and major subject of a measure of legal protection or unable to consent.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01841060
Start Date
November 1 2008
End Date
December 1 2011
Last Update
January 19 2021
Active Locations (9)
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1
CHU de Bordeaux
Bordeaux, France, 33076
2
Hôpital Cochin
Paris, France, 75000
3
Hôpital Européen Georges Pompidou
Paris, France, 75908
4
Hôpital de Tenon
Paris, France, 75970