Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT00180856
Status:
COMPLETED
Last Update Posted:
2005-09-16
First Post:
2005-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiofrequency Ablation of Lung Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2005-09-11', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incomplete local treatment'}], 'secondaryOutcomes': [{'measure': 'Survival'}, {'measure': 'Lung disease-free survival'}]}, 'conditionsModule': {'keywords': ['Lung metastasis', 'Lung cancer', 'Radiofrequency ablation'], 'conditions': ['Lung Cancer', 'Metastasis']}, 'descriptionModule': {'briefSummary': 'Radiofrequency ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that radiofrequency can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms. The aim of the study is to prospectively evaluate local efficacy with a minimal follow-up of one year, tolerance, lung disease-free survival and survival after radiofrequency ablation of lung tumors (primary lung cancer or lung metastases).', 'detailedDescription': 'Radiofrequency (RF) ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that RF can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms with a minimal follow-up of one year. The primary endpoint was to determine the rate of incomplete local treatment at 1 year. The secondary endpoints were to evaluate tolerance, survival, disease-free survival and lung tumor-free survival. Patients are followed-up by CT scan examination at day 1 or 2 before discharge from the hospital, then at 2, 4, 6, 9 and 12 months and then at 2 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral or bilateral unresectable primary or metastatic lung tumors \\<= 40 mm and a number of tumor \\<=5\n* Tumors located more than 1 cm from the hilum, and not involving soft tissues or mediastinum.\n* Malignancy histologically proven for pulmonary nodules in patients with no history of cancer outside the lung.\n* Lung tumors in patients with a known distant cancer history, has to be either histologically proven or a demonstrated change in size of at least 25% in their largest diameter is required on CT during the previous year\n* Pretreatment imaging work-up within 4 weeks of scheduled RF ablation (at least a chest CT and an abdomino-pelvic CT)\n* If a tumor is found outside the lung, it has to be amenable to complete eradication with RF or RF plus surgery\n* Lung spirometry within 4 weeks of treatment with a FEV1 \\>= 1 liter\n* Written informed consent.\n\nExclusion Criteria:\n\n* Uncorrectable coagulopathy with a prothrombin time greater than 1.5 and a platelet count below 106/mm3'}, 'identificationModule': {'nctId': 'NCT00180856', 'briefTitle': 'Radiofrequency Ablation of Lung Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'A Phase II Study of Radiofrequency Ablation of Lung Tumors', 'orgStudyIdInfo': {'id': 'RFPULM'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radiofrequency ablation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33 000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonié', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Thierry De Baere, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}, {'name': 'Jean Pallussière, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Bergonié'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}}}}