Radiofrequency Ablation of Lung Tumors

NCT ID: NCT00180856

Last Updated: 2005-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31

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

Conditions

Lung Cancer; Metastasis

Keywords

Lung metastasis; Lung cancer; Radiofrequency ablation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Radiofrequency ablation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Principal Investigators

Thierry De Baere, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Jean Pallussière, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

Institut Bergonié

Bordeaux, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

RFPULM

Identifier Type: -

Identifier Source: org_study_id