Trial Outcomes & Findings for Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive (NCT NCT01841060)
NCT ID: NCT01841060
Last Updated: 2021-01-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
one year after percutaneous radiofrequency ablation (RFA)
Results posted on
2021-01-19
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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42
|
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Overall Study
COMPLETED
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32
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Protocol Violation
|
10
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Treated With Radiofrequency Ablation (RFA)
n=42 Participants
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.
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|---|---|
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Age, Continuous
|
71.7 years
STANDARD_DEVIATION 8.0 • n=42 Participants
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|
Sex: Female, Male
Female
|
13 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=42 Participants
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Region of Enrollment
France
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42 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: one year after percutaneous radiofrequency ablation (RFA)Population: Patients alive at one year
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.
Outcome measures
| Measure |
Patients Treated With Radiofrequency Ablation (RFA)
n=32 Participants
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.
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|---|---|
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Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)
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5 Participants
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SECONDARY outcome
Timeframe: three years after percutaneous radiofrequency ablation (RFA)Population: Patients alive at three years
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.
Outcome measures
| Measure |
Patients Treated With Radiofrequency Ablation (RFA)
n=16 Participants
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.
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|---|---|
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Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA)
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 year after RFAOS 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.
Outcome measures
| Measure |
Patients Treated With Radiofrequency Ablation (RFA)
n=36 Participants
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.
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|---|---|
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1-year Overall Survival (OS) Rate
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33 Participants
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SECONDARY outcome
Timeframe: 3 years after RFAOS 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.
Outcome measures
| Measure |
Patients Treated With Radiofrequency Ablation (RFA)
n=36 Participants
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.
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|---|---|
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3-year Overall Survival (OS) Rate
|
21 Participants
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Adverse Events
Radiofrequency Ablathermy
Serious events: 2 serious events
Other events: 3 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Radiofrequency Ablathermy
n=42 participants at risk
Percutaneous radiofrequency ablation (RFA)
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|---|---|
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Vascular disorders
Thromboembolic event
|
2.4%
1/42 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
2.4%
1/42 • Number of events 1 • 3 years
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Other adverse events
| Measure |
Radiofrequency Ablathermy
n=42 participants at risk
Percutaneous radiofrequency ablation (RFA)
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Dyspnea
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4.8%
2/42 • Number of events 2 • 3 years
|
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Injury, poisoning and procedural complications
fracture
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2.4%
1/42 • Number of events 1 • 3 years
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place