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Radiofrequency Ablation of Lung Tumors

This study has been completed.
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00180856
First received: September 11, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Lung Cancer
Metastasis
 Procedure: Radiofrequency ablation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Radiofrequency Ablation of Lung Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Incomplete local treatment

Secondary Outcome Measures:
  • Survival
  • Lung disease-free survival

Estimated Enrollment: 60
Study Start Date: January 2002
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180856

Locations
France
Institut Bergonié
Bordeaux, France, 33 000
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Thierry De Baere, MD Institut Gustave Roussy
Principal Investigator: Jean Pallussière, MD Institut Bergonié
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180856     History of Changes
Other Study ID Numbers: RFPULM
Study First Received: September 11, 2005
Last Updated: September 11, 2005
Health Authority: France: Ministry of Health

Keywords provided by Institut Gustave Roussy:
Lung metastasis
Lung cancer
Radiofrequency ablation

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013