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Clinical Trials/NCT01841060
NCT01841060
Completed
Not Applicable

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

Institut Bergonié9 sites in 1 country42 target enrollmentNovember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Non-small Cell Neoplasm of Lung Stage Ia
Sponsor
Institut Bergonié
Enrollment
42
Locations
9
Primary Endpoint
Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
December 2011
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)

Time Frame: one year after percutaneous radiofrequency ablation (RFA)

local control is defined as the absence of progression of the ablated site. rate is defined as the number of alive patient without local progression divided by the number of patients alive at one year.

Secondary Outcomes

  • 3-year Overall Survival (OS) Rate(3 years after RFA)
  • Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA)(three years after percutaneous radiofrequency ablation (RFA))
  • 1-year Overall Survival (OS) Rate(1 year after RFA)

Study Sites (9)

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