Back to resultsRadiofrequency Ablation of Lung Tumors
Primary Purpose
Lung Cancer, Metastasis
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring Lung metastasis, Lung cancer, Radiofrequency ablation
Eligibility Criteria
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
Sites / Locations
- Institut Bergonié
- Institut Gustave Roussy
Outcomes
Primary Outcome Measures
Incomplete local treatment
Secondary Outcome Measures
Survival
Lung disease-free survival
Full Information
NCT ID
NCT00180856
First Posted
September 11, 2005
Last Updated
September 11, 2005
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00180856
Brief Title
Radiofrequency Ablation of Lung Tumors
Official Title
A Phase II Study of Radiofrequency Ablation of Lung Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. Study Description
Brief Summary
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).
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Metastasis
Keywords
Lung metastasis, Lung cancer, Radiofrequency ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Primary Outcome Measure Information:
Title
Incomplete local treatment
Secondary Outcome Measure Information:
Title
Survival
Title
Lung disease-free survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry De Baere, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Pallussière, MD
Organizational Affiliation
Institut Bergonié
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33 000
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
12. IPD Sharing Statement
Learn more about this trial
Radiofrequency Ablation of Lung Tumors
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