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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency ablathermy | Experimental | Percutaneous radiofrequency ablation (RFA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Local Tumor Control Rate 1 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. | one year after percutaneous radiofrequency ablation (RFA) |
| Measure | Description | Time Frame |
|---|---|---|
| Local Tumor Control Rate 3 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. | three years after percutaneous radiofrequency ablation (RFA) |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Jean PALUSSIERE, MD | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33076 | France | |||
| Hôpital Cochin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30143031 | Result | Palussiere 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Treated With Radiofrequency Ablation (RFA) | RFA treatment: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients treated with Radiofrequency ablation (RFA)
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated With Radiofrequency Ablation (RFA) | RFA treatment: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Tumor Control Rate 1 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. | Patients alive at one year | Posted | Count of Participants | Participants | one year after percutaneous radiofrequency ablation (RFA) |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiofrequency Ablathermy | Percutaneous radiofrequency ablation (RFA) | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thromboembolic event | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Simone Mathoulin-Pélissier | Institut Bergonie | 33556333333 | s.mathoulin@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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|
| 1-year Overall Survival (OS) Rate | 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. | 1 year after RFA |
| 3-year Overall Survival (OS) Rate | 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. | 3 years after RFA |
| Paris |
| 75000 |
| France |
| Hôpital Européen Georges Pompidou | Paris | 75908 | France |
| Hôpital de Tenon | Paris | 75970 | France |
| CH de Pau | Pau | 64000 | France |
| CHU de Rennes | Rennes | 35033 | France |
| CHU de Strasbourg | Strasbourg | 67091 | France |
| CHU Rangueil-Larrey | Toulouse | 31059 | France |
| Institut Gustave Roussy | Villejuif | 94800 | France |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Local Tumor Control Rate 3 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. | Patients alive at three years | Posted | Count of Participants | Participants | three years after percutaneous radiofrequency ablation (RFA) |
|
|
|
| Secondary | 1-year Overall Survival (OS) Rate | 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. | Posted | Count of Participants | Participants | 1 year after RFA |
|
|
|
| Secondary | 3-year Overall Survival (OS) Rate | 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. | Posted | Count of Participants | Participants | 3 years after RFA |
|
|
|
| 42 |
| 2 |
| 42 |
| 3 |
| 42 |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
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| D013514 |
| Surgical Procedures, Operative |