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

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ClinicalTrials.gov Identifier: NCT01841060
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : April 26, 2013
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Institut Bergonié

Study Description
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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.

Condition or disease Intervention/treatment Phase
Malignant Non-small Cell Neoplasm of Lung Stage Ia Procedure: Radiofrequency Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 Start Date : November 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Radiofrequency ablathermy
Radiofrequency ablathermy
 Procedure: Radiofrequency
Radiofrequency


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 07/2011 (1 year) ]
    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


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 07/2011 (1 and 3 years) ]
    • Evaluation of overall survival at 1 and 3 years Bookseller local control rates at 3 years, Evaluation of respiratory function before and after treatment, Assessment of quality of life before and after treatment, Evaluation of tolerance to treatment: side effects and complications associated with the technique, Evaluation of the duration of hospitalization, Performance Evaluation of the PET in the diagnosis of tumor progression

  2. Evaluation of overall survival at 1 and 3 years, the local control rates at 3 years, lung function before and after treatment, quality of life before and after treatment, the tolerability [ Time Frame: 07/2011 (1 and 3 years) ]
    Evaluation of overall survival at 1 and 3 years, the local control rates at 3 years, lung function before and after treatment, quality of life before and after treatment, the tolerability


Other Outcome Measures:
  1. Evaluation of the duration of hospitalization, Performance Evaluation of the PET in the diagnosis of tumor progression [ Time Frame: 07/2011 (1 and 3 years) ]
    Evaluation of the duration of hospitalization, Performance Evaluation of the PET in the diagnosis of tumor progression


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841060


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33076
Hôpital Cochin
Paris, France, 75000
Hôpital Européen Georges Pompidou
Paris, France, 75908
Hôpital de Tenon
Paris, France, 75970
CH de Pau
Pau, France, 64000
CHU de Rennes
Rennes, France, 35033
CHU de Strasbourg
Strasbourg, France, 67091
CHU Rangueil-Larrey
Toulouse, France, 31059
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Institut Bergonié
Ministry of Health, France
Investigators
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Study Chair: Jean PALUSSIERE, MD Institut Bergonié
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01841060    
Other Study ID Numbers: IB2008-34
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013
Keywords provided by Institut Bergonié:
Malignant Non-small Cell Neoplasm of Lung
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases