Completed

NCT Number: NCT01841060

Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive

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.

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Key information

Conditions

Malignant Non-small Cell Neoplasm of Lung Stage Ia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux, Bordeaux, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous radiofrequency ablation (RFA)

Procedure

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.

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

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.

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Collaborators

Ministry of Health, France

Registry information

Official study title

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

Acronym: PARF2008

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Apr 26, 2013
Registry last updated: Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.