A phase II study of percutaneous radiofrequency ablation for malignant lung tumor (JIVROSG-0702)

UMIN ID: UMIN000001502

Registered date:12/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant lung tumor
• Date of first enrollment: 2008/04/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Following the percutaneous insertion of a radiofrequency needle, radiofrequency ablation of lung tumor is to be performed.

Outcome(s)

• Primary Outcome: Rate of complete response (CR) on FDG-PET
• Secondary Outcome: Adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare