Status:
COMPLETED
Radiofrequency Ablation of Lung Tumors
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Lung Cancer
Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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
- Uncorrectable coagulopathy with a prothrombin time greater than 1.5 and a platelet count below 106/mm3
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00180856
Start Date
January 1 2002
Last Update
September 16 2005
Active Locations (2)
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1
Institut Bergonié
Bordeaux, France, 33 000
2
Institut Gustave Roussy
Villejuif, France, 94800