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

Phase 2

• Conditions: Malignant lung tumor

• Registration Number: JPRN-UMIN000001502
• Lead Sponsor: Japan Interventional Radiology in Oncology Study Group (JIVROSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-12
• Study Completion: 2012-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of complete response (CR) on FDG-PET

Secondary Outcome Measures

Name	Time	Method
Adverse events