Malignant Non-small Cell Neoplasm of Lung Stage IaPARF2008NCT01841060
Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive
A study testing Percutaneous radiofrequency ablation (RFA) in people with Malignant Non-small Cell Neoplasm of Lung Stage Ia, run by Institut Bergonié at 9 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Non-small Cell Neoplasm of Lung Stage Ia
- What is being tested?
- Percutaneous radiofrequency ablation (RFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 9 sitesFrance
- Study dates
- Nov 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU de Bordeaux
Bordeaux, 33076
Hôpital Cochin
Paris, 75000
Hôpital Européen Georges Pompidou
Paris, 75908
Hôpital de Tenon
Paris, 75970
CH de Pau
Pau, 64000
CHU de Rennes
Rennes, 35033
CHU de Strasbourg
Strasbourg, 67091
CHU Rangueil-Larrey
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National
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.
Read the 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
- Being tested
- Percutaneous radiofrequency ablation (RFA)
- Keywords
- Malignant Non-small Cell Neoplasm of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous radiofrequency ablation (RFA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablathermy | Experimental | Percutaneous radiofrequency ablation (RFA) Receives: Procedure: Percutaneous radiofrequency ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year after percutaneous radiofrequency ablation (RFA)
Secondary outcomes (3)
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.
Measured: three years after percutaneous radiofrequency ablation (RFA)
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.
Measured: 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.
Measured: 3 years after RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startNov 2008
- Primary completionJul 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Non-small Cell Neoplasm of Lung Stage IaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jean PALUSSIERE, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841060
- Sponsor's protocol ID
- IB2008-34
- Acronym
- PARF2008
- Status last verified
- Jan 2021
- First submitted
- 29 Oct 2012
- Last updated
- 19 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30143031
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National
- ClinicalTrials.gov ID
- NCT01841060
- Acronym / sponsor ID
- PARF2008 / IB2008-34
- Keywords
- Malignant Non-small Cell Neoplasm of Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Nov 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Posted 19 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablathermy | Experimental | Procedure: Percutaneous radiofrequency ablation (RFA)Percutaneous radiofrequency ablation (RFA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Radiofrequency ablathermy |
Primary outcome
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.
3 secondary outcomes
Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA)
Time frame: three years after percutaneous radiofrequency ablation (RFA)
1-year Overall Survival (OS) Rate
Time frame: 1 year after RFA
3-year Overall Survival (OS) Rate
Time frame: 3 years after RFA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30143031Palussiere 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean PALUSSIERE, MD study chair
Institut Bergonié
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous radiofrequency ablation (RFA) in people with Malignant Non-small Cell Neoplasm of Lung Stage Ia, run by Institut Bergonié at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA) (time frame: one year after percutaneous radiofrequency ablation (RFA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01841060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.