Clinical trial NCT00180856: Radiofrequency Ablation of Lung Tumors
Official title: A Phase II Study of Radiofrequency Ablation of Lung Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Metastasis
Keywords: Lung metastasis
Lung cancer
Radiofrequency ablation
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Incomplete local treatment
Secondary outcomes:
measure: Survival
measure: Lung disease-free survival
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Thierry De Baere, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Bergonié
name: Jean Pallussière, MD
role: PRINCIPAL_INVESTIGATOR
References: