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Completed

NCT Number: NCT00180856

Radiofrequency Ablation of Lung Tumors

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Bergonié, Bordeaux, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation

Procedure

Primary outcomes

  1. Incomplete local treatment

Secondary outcomes

  1. Survival

  2. Lung disease-free survival

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Official study title

A Phase II Study of Radiofrequency Ablation of Lung Tumors

Important dates

Study start
2002
First posted
Sep 16, 2005
Registry last updated
Sep 16, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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