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
Results First Posted : January 18, 2021
Last Update Posted : January 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Malignant Non-small Cell Neoplasm of Lung Stage Ia||Procedure: Percutaneous radiofrequency ablation (RFA)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|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|
Experimental: Radiofrequency ablathermy
Percutaneous radiofrequency ablation (RFA)
Procedure: Percutaneous radiofrequency ablation (RFA)
Computed tomography (CT) was used to treat tumors under general anesthesia. Thoracic epidural anesthesia was administered in case of contraindication to general anesthesia mostly due to poor respiratory function. All patients were treated with the same multitine electrodes (LeVeen; Boston Scientific, Nattick. MA) measuring 3, 3.5, or 4 cm in diameter and at least 10 mm larger than the diameter of the target tumor. Multiple overlapping ablations were performed, when needed, in different parts of the tumor in order to cover the entire volume.
- 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.
- Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA) [ Time Frame: three years 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 thee years.
- 1-year Overall Survival (OS) Rate [ Time Frame: 1 year after RFA ]OS was defined as the time from RFA treatment to death, whatever the cause. If the patient was still alive at the end of study or lost to follow-up, the patient was censored at the date of last news. 1-year overall survival rate was estimated using the Kaplan-Meier estimator.
- 3-year Overall Survival (OS) Rate [ Time Frame: 3 years after RFA ]OS was defined as the time from RFA treatment to death, whatever the cause. If the patient was still alive at the end of study or lost to follow-up, the patient was censored at the date of last news.
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
|CHU de Bordeaux|
|Bordeaux, France, 33076|
|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|
|Toulouse, France, 31059|
|Institut Gustave Roussy|
|Villejuif, France, 94800|
|Study Chair:||Jean PALUSSIERE, MD||Institut Bergonié|