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
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Radiofrequency ablathermy
Percutaneous radiofrequency ablation (RFA)
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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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
- Patients over 18 years
- Histological diagnosis of non-small cell lung tumor established.
- Stage 1A tumors (lesions <= 3 cm, N0) report prepared by PET and CT
- Surgical treatment of the lesion contrindiqué or refused by the patient,
- ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP)
- Expectancy greater than 6 months life
- PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV> = 2.5) at the lesion to be treated,
- Signed informed consent,
- Patient affiliated to a social security scheme.
Exclusion criteria :
- 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)
- Disorder of uncontrolled bleeding (TP <50% TCA> 1.5 x control).
- Abnormal blood count platelets <90000/mm3
- Cons-indication to general anesthesia
- Patient with a cardiac pacemaker if a review indicates treatment against ARF
- pregnancy
- Patient included in another clinical study
- Unable to undergo medical monitoring test for geographical, social or psychological reasons,
- Private patient freedom and major subject of a measure of legal protection or unable to consent.

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
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 |
Study Chair: | Jean PALUSSIERE, MD | Institut Bergonié |
Responsible Party: | Institut Bergonié |
ClinicalTrials.gov Identifier: | NCT01841060 |
Other Study ID Numbers: |
IB2008-34 |
First Posted: | April 26, 2013 Key Record Dates |
Results First Posted: | January 18, 2021 |
Last Update Posted: | January 18, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Malignant Non-small Cell Neoplasm of Lung |
Lung Neoplasms Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases |