Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT01841060
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2012-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's.mathoulin@bordeaux.unicancer.fr', 'phone': '33556333333', 'title': 'Pr Simone Mathoulin-Pélissier', 'organization': 'Institut Bergonie'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Radiofrequency Ablathermy', 'description': 'Percutaneous radiofrequency ablation (RFA)', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 3, 'seriousNumAtRisk': 42, 'deathsNumAffected': 15, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Radiofrequency Ablation (RFA)', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'one year after percutaneous radiofrequency ablation (RFA)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients alive at one year'}, {'type': 'SECONDARY', 'title': 'Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Radiofrequency Ablation (RFA)', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'three years after percutaneous radiofrequency ablation (RFA)', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients alive at three years'}, {'type': 'SECONDARY', 'title': '1-year Overall Survival (OS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Radiofrequency Ablation (RFA)', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year after RFA', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '3-year Overall Survival (OS) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With Radiofrequency Ablation (RFA)', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 years after RFA', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients Treated With Radiofrequency Ablation (RFA)', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Treated With Radiofrequency Ablation (RFA)', 'description': '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '71.7', 'spread': '8.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patients treated with Radiofrequency ablation (RFA)'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2012-10-29', 'resultsFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2013-04-23', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-12', 'studyFirstPostDateStruct': {'date': '2013-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Tumor Control Rate 1 Year After Percutaneous Radiofrequency Ablation (RFA)', 'timeFrame': 'one year after percutaneous radiofrequency ablation (RFA)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Local Tumor Control Rate 3 Years After Percutaneous Radiofrequency Ablation (RFA)', 'timeFrame': 'three years after percutaneous radiofrequency ablation (RFA)', 'description': '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.'}, {'measure': '1-year Overall Survival (OS) Rate', 'timeFrame': '1 year after RFA', 'description': '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.'}, {'measure': '3-year Overall Survival (OS) Rate', 'timeFrame': '3 years after RFA', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Malignant Non-small Cell Neoplasm of Lung'], 'conditions': ['Malignant Non-small Cell Neoplasm of Lung Stage Ia']}, 'referencesModule': {'references': [{'pmid': '30143031', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThis 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n1. Patients over 18 years\n2. Histological diagnosis of non-small cell lung tumor established.\n3. Stage 1A tumors (lesions \\<= 3 cm, N0) report prepared by PET and CT\n4. Surgical treatment of the lesion contrindiqué or refused by the patient,\n5. ARF considered technically feasible after discussing the case in a multidisciplinary meeting (RCP)\n6. Expectancy greater than 6 months life\n7. PET before inclusion (8 weeks maximum before radiofrequency) showing uptake (SUV\\> = 2.5) at the lesion to be treated,\n8. Signed informed consent,\n9. Patient affiliated to a social security scheme.\n\nExclusion criteria :\n\n1. 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)\n2. Disorder of uncontrolled bleeding (TP \\<50% TCA\\> 1.5 x control).\n3. Abnormal blood count platelets \\<90000/mm3\n4. Cons-indication to general anesthesia\n5. Patient with a cardiac pacemaker if a review indicates treatment against ARF\n6. pregnancy\n7. Patient included in another clinical study\n8. Unable to undergo medical monitoring test for geographical, social or psychological reasons,\n9. Private patient freedom and major subject of a measure of legal protection or unable to consent.'}, 'identificationModule': {'nctId': 'NCT01841060', 'acronym': 'PARF2008', 'briefTitle': 'Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive', 'organization': {'class': 'OTHER', 'fullName': 'Institut Bergonié'}, 'officialTitle': 'Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National', 'orgStudyIdInfo': {'id': 'IB2008-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiofrequency ablathermy', 'description': 'Percutaneous radiofrequency ablation (RFA)', 'interventionNames': ['Procedure: Percutaneous radiofrequency ablation (RFA)']}], 'interventions': [{'name': 'Percutaneous radiofrequency ablation (RFA)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Radiofrequency ablathermy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '75000', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75908', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75970', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital de Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '64000', 'city': 'Pau', 'country': 'France', 'facility': 'CH de Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Rangueil-Larrey', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Jean PALUSSIERE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Bergonié'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Bergonié', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}