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


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Non-small Cell Neoplasm of Lung Stage Ia

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Trial Information

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


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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Evaluation of the effectiveness of local ablathermy radiofrequency (RF) lung tumors primitive stage IA non-surgical patients. The effectiveness will be evaluated in terms of local control rate at 1 year

Outcome Description:

Evaluation of the effectiveness of local ablathermy radiofrequency (RF) lung tumors primitive stage IA non-surgical patients. The effectiveness will be evaluated in terms of local control rate at 1 year

Outcome Time Frame:

07/2011 (1 year)

Safety Issue:

No

Principal Investigator

Jean PALUSSIERE, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IB2008-34

NCT ID:

NCT01841060

Start Date:

November 2008

Completion Date:

December 2011

Related Keywords:

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

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