Lung Cancer, Metastasis
Conditions
Keywords
Lung metastasis, Lung cancer, Radiofrequency ablation
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
Interventions
PROCEDURERadiofrequency ablation
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incomplete local treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival | — |
| Lung disease-free survival | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORThierry De Baere, MD
Gustave Roussy, Cancer Campus, Grand Paris
PRINCIPAL_INVESTIGATORJean Pallussière, MD
Institut Bergonié
Outcome results
None listed