Malignant lung tumor
Conditions
Interventions
Following the percutaneous insertion of a radiofrequency needle, radiofrequency ablation of lung tumor is to be performed.
Sponsors
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria were as follows: (i) has either a histologically confirmed NSCLC in clinical stage IA, a histologically confirmed intrapulmonary recurrence of NSCLC after curative resection without nodal metastasis or after chemoradiotherapy maintaining complete response (CR) for >=1 year, or a metastatic lung cancer with histologically proven extra-pulmonary primary tumor; (ii) maximum tumor diameter of 1.0-2.5 cm; (iii) distance between the target lesion and visceral pleura was>= 5 mm; (iv) FDG accumulation at the target lesion was considered malignant; (v) non-surgical candidate or refusal of surgery; (vi) no distant metastasis other than the lung; (vii) all lung tumors were treatable; (viii) adequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions; (ix) age of >= years; (x) performance status (ECOG) of 0-2; (xi) life expectancy >= 2 months; (xii) provided written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria consisted of the following: (i) placement of a cardiac pacemaker; (ii) difficulty placing an electrode without penetrating a pulmonary vessel of >=5 mm in diameter; (iii) contact with the heart, aorta, mediastinum, or bronchus/pulmonary vessel of >= 5 mm in diameter; (iv) severe impairment of the contralateral lung; (v) presence of pulmonary hypertension; (vi) presence of a coagulation abnormality; (vii) difficulty in or inability to discontinue anti-platelet or anti-coagulation medications; (viii) an active infection or >=1.0 mg/dL C-reactive protein; (x) fever>=38 degree; (xi) inability to delay the treatment of a non-target lesion more than 4 weeks after protocol treatment; (xii) previous radiotherapy around the target lesion; (xiii) pregnancy or possible pregnancy; (xiv) ineligibility determined by the responding physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete response (CR) on FDG-PET | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
Japan
Contacts
Public ContactYasuaki Arai
JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
Outcome results
None listed