Radiofrequency Ablation of Lung Tumors

NCT00180856 | Completed Phase 2

• 1 other identifier: RFPULM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Lung Cancer; Metastasis

Keywords

Lung metastasis; Lung cancer; Radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Incomplete local treatment

Secondary Outcomes (2)

• Survival

• Lung disease-free survival

Interventions

Radiofrequency ablation PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Uncorrectable coagulopathy with a prothrombin time greater than 1.5 and a platelet count below 106/mm3

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (2)

Institut Bergonié

Bordeaux, 33 000, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Thierry De Baere, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

• Jean Pallussière, MD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 16, 2005
• Study Start: January 1, 2002
• Last Updated: September 16, 2005

Record last verified: 2005-09

Locations

FR (2)