UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of percutaneous radiofrequency ablation for malignant lung tumor (JIVROSG-0702)
Title of the study (Brief title)	Percutaneous radiofrequency ablation for malignant lung tumor (JIVROSG-0702)
Region	Japan

Condition
Condition	Malignant lung tumor
Classification by specialty	Pneumology Hematology and clinical oncology Chest surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of percutaneous radiofrequency ablation for malignant lung tumor.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Rate of complete response (CR) on FDG-PET
Key secondary outcomes	Adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Following the percutaneous insertion of a radiofrequency needle, radiofrequency ablation of lung tumor is to be performed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key 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.
Target sample size	33

Research contact person
Name of lead principal investigator	Susumu Kanazawa
Organization	Okayama University
Division name	Department of Radiology
Address	Department of Radiology
TEL	086-252-1111
Email	msone@me.com

Public contact
Name of contact person	Yasuaki Arai
Organization	JIVROSG, Coordinating Office
Division name	Division of Diagnostic Radiology, National Cancer Center Hospital
Address	5-1-1, Tsukiji, Chu0-ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Homepage URL	http://jivrosg.umin.jp/
Email	jivrosgoffice@ml.res.ncc.go.jp

Sponsor
Institute	Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2008 Year 11 Month 12 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2008 Year 02 Month 29 Day
Anticipated trial start date	2008 Year 04 Month 01 Day
Last follow-up date	2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2008 Year 11 Month 12 Day
Last modified on	2016 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001485