NCT Number: NCT00180856
Radiofrequency Ablation of Lung Tumors
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).
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Institut Bergonié, Bordeaux, France
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Unilateral or bilateral unresectable primary or metastatic lung tumors <= 40 mm and a number of tumor <=5
- Tumors located more than 1 cm from the hilum, and not involving soft tissues or mediastinum.
- Malignancy histologically proven for pulmonary nodules in patients with no history of cancer outside the lung.
- 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
- Pretreatment imaging work-up within 4 weeks of scheduled RF ablation (at least a chest CT and an abdomino-pelvic CT)
- If a tumor is found outside the lung, it has to be amenable to complete eradication with RF or RF plus surgery
- Lung spirometry within 4 weeks of treatment with a FEV1 >= 1 liter
- Written informed consent.
Exclusion criteria
- Uncorrectable coagulopathy with a prothrombin time greater than 1.5 and a platelet count below 106/mm3
Treatment and study plan
Primary outcomes
-
Incomplete local treatment
Secondary outcomes
-
Survival
-
Lung disease-free survival
Sponsors and collaborators
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Other
Registry information
Official study title
A Phase II Study of Radiofrequency Ablation of Lung Tumors
Important dates
- Study start
- 2002
- First posted
- Sep 16, 2005
- Registry last updated
- Sep 16, 2005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer
NCT02917993
Behavior, Bronchial Neoplasms
La Jolla, California, United States
View Trial DetailsEvaluation of an Automated System to Culture Metastatic Patient Circulating Tumor Cells in Embryonated Chicken Eggs (in Ovo Culture)
NCT05472532
Adnexal Diseases, Breast Cancer
Pierre-Bénite, France
View Trial DetailsArginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors
NCT02903914
Adenocarcinoma, Adenoma
Mobile, Alabama, United States
View Trial DetailsCombined Deep Inspiration Breath Hold (DIBH)-Expiration Planning Technique in Patients With Lung Tumors in Close Proximity to the Chest Wall
NCT04507828
Lung Cancer, Lung Diseases
Indianapolis, Indiana, United States
View Trial Details