Radiofrequency Ablation of Lung Tumors

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Radiofrequency Ablation of Lung Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180856
• Other study ID #: RFPULM
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2005
• Last updated: September 11, 2005
• Start date: January 2002

Study information

• Verified date: September 2005
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Metastasis

Intervention

Procedure:
• Radiofrequency ablation

Locations

Country	Name	City	State
France	Institut Bergonié	Bordeaux
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incomplete local treatment
Secondary	Survival
Secondary	Lung disease-free survival