A Phase II Study of Radiofrequency Ablation of Lung Tumors
18 Years
N/A
Both
Lung Cancer, Metastasis
Trial Information
A Phase II Study of Radiofrequency Ablation of Lung Tumors
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incomplete local treatment
Principal Investigator
Thierry De Baere, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
France: Ministry of Health
Study ID:
RFPULM
NCT ID:
NCT00180856
Start Date:
January 2002
Completion Date:
Related Keywords:
- Lung Cancer
- Metastasis
- Lung metastasis
- Lung cancer
- Radiofrequency ablation
- Lung Neoplasms
- Neoplasm Metastasis
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