NIPH Clinical Trials Search

UMIN ID: UMIN000001502

Registered date:12/11/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMalignant lung tumor
Date of first enrollment2008/04/01
Target sample size33
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Following the percutaneous insertion of a radiofrequency needle, radiofrequency ablation of lung tumor is to be performed.


Primary OutcomeRate of complete response (CR) on FDG-PET
Secondary OutcomeAdverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaExclusion 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


public contact
Name Yasuaki Arai
Address 5-1-1, Tsukiji, Chu0-ku, Tokyo, 104-0045, Japan Japan
Telephone 03-3542-2511
Affiliation JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
scientific contact
Name Susumu Kanazawa
Address Department of Radiology Japan
Telephone 086-252-1111
Affiliation Okayama University Department of Radiology