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Sponsored by: |
Institut Gustave Roussy |
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Information provided by: | Institut Gustave Roussy |
ClinicalTrials.gov Identifier: | NCT00180856 |
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).
Condition | Intervention | Phase |
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Lung Cancer Metastasis |
Procedure: Radiofrequency ablation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Radiofrequency Ablation of Lung Tumors |
Estimated Enrollment: | 60 |
Study Start Date: | January 2002 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Institut Gustave Roussy | |
Villejuif, France, 94800 | |
Institut Bergonié | |
Bordeaux, France, 33 000 |
Principal Investigator: | Thierry De Baere, MD | Institut Gustave Roussy |
Principal Investigator: | Jean Pallussière, MD | Institut Bergonié |
Study ID Numbers: | RFPULM |
Study First Received: | September 11, 2005 |
Last Updated: | September 11, 2005 |
ClinicalTrials.gov Identifier: | NCT00180856 |
Health Authority: | France: Ministry of Health |
Lung metastasis Lung cancer Radiofrequency ablation |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasm Metastasis |
Respiratory Tract Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |