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Radiofrequency Ablation of Lung Tumors

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ClinicalTrials.gov Identifier: NCT00180856
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 16, 2005
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

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).

Condition or disease Intervention/treatment Phase
Lung Cancer Metastasis Procedure: Radiofrequency ablation Phase 2

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Radiofrequency Ablation of Lung Tumors
Study Start Date : January 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Incomplete local treatment

Secondary Outcome Measures :
  1. Survival
  2. Lung disease-free survival


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180856


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

ClinicalTrials.gov Identifier: NCT00180856     History of Changes
Other Study ID Numbers: RFPULM
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 16, 2005
Last Verified: September 2005

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Lung metastasis
Lung cancer
Radiofrequency ablation

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes