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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

Tracking Information
First Submitted Date  ICMJE October 29, 2012
First Posted Date  ICMJE April 26, 2013
Last Update Posted Date April 26, 2013
Study Start Date  ICMJE November 2008
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2013)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 23, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive
Official Title  ICMJE Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Malignant Non-small Cell Neoplasm of Lung Stage Ia
Intervention  ICMJE Procedure: Radiofrequency
Radiofrequency
Study Arms  ICMJE Experimental: Radiofrequency ablathermy
Radiofrequency ablathermy
Intervention: Procedure: Radiofrequency
Publications * Palussière 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2013)
43
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01841060
Other Study ID Numbers  ICMJE IB2008-34
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Bergonié
Study Sponsor  ICMJE Institut Bergonié
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Study Chair: Jean PALUSSIERE, MD Institut Bergonié
PRS Account Institut Bergonié
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP