Malignant Non-small Cell Neoplasm of Lung Stage Ia
Conditions
Keywords
Malignant Non-small Cell Neoplasm of Lung
Brief summary
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.
Detailed description
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
Interventions
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.
Sponsors
Ministry of Health, France
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: 1. Patients over 18 years 2. Histological diagnosis of non-small cell lung tumor established. 3. Stage 1A tumors (lesions \<= 3 cm, N0) report prepared by PET and CT 4. Surgical treatment of the lesion contrindiqué or refused by the patient, 5. ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP) 6. Expectancy greater than 6 months life 7. PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV\> = 2.5) at the lesion to be treated, 8. Signed informed consent, 9. Patient affiliated to a social security scheme.
Exclusion criteria
: 1. 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) 2. Disorder of uncontrolled bleeding (TP \<50% TCA\> 1.5 x control). 3. Abnormal blood count platelets \<90000/mm3 4. Cons-indication to general anesthesia 5. Patient with a cardiac pacemaker if a review indicates treatment against ARF 6. pregnancy 7. Patient included in another clinical study 8. Unable to undergo medical monitoring test for geographical, social or psychological reasons, 9. Private patient freedom and major subject of a measure of legal protection or unable to consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA) | 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 | 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 | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 10 |
Baseline characteristics
| Characteristic | Patients Treated With Radiofrequency Ablation (RFA) | — |
|---|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 42 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 29 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 15 / 42 |
| other Total, other adverse events | 3 / 42 |
| serious Total, serious adverse events | 2 / 42 |
Outcome results
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.
Time frame: one year after percutaneous radiofrequency ablation (RFA)
Population: Patients alive at one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Treated With Radiofrequency Ablation (RFA) | Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA) | 5 Participants |
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.
Time frame: 1 year after RFA
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Treated With Radiofrequency Ablation (RFA) | 1-year Overall Survival (OS) Rate | 33 Participants |
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.
Time frame: 3 years after RFA
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Treated With Radiofrequency Ablation (RFA) | 3-year Overall Survival (OS) Rate | 21 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.
Time frame: three years after percutaneous radiofrequency ablation (RFA)
Population: Patients alive at three years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Treated With Radiofrequency Ablation (RFA) | Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA) | 3 Participants |