UMIN-CTR Clinical Trial

Public title

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

Acronym

Percutaneous radiofrequency ablation for malignant lung tumor (JIVROSG-0702)

Scientific Title

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

Scientific Title:Acronym

Percutaneous radiofrequency ablation for malignant lung tumor (JIVROSG-0702)

Region

Japan

Condition

Malignant lung tumor

Classification by specialty

Pneumology	Hematology and clinical oncology	Chest surgery
Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Rate of complete response (CR) on FDG-PET

Key secondary outcomes

Adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Susumu Kanazawa

Organization

Okayama University

Division name

Department of Radiology

Zip code

Address

Department of Radiology

TEL

086-252-1111

Email

msone@me.com

Name of contact person

1st name
Middle name
Last name	Yasuaki Arai

Organization

JIVROSG, Coordinating Office

Division name

Division of Diagnostic Radiology, National Cancer Center Hospital

Zip code

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

Institute

Japan Interventional Radiology in Oncology Study Group (JIVROSG)

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

11

Month

12

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2008

Year

02

Month

29

Day

Date of IRB

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

Other related information

Registered date

2008

Year

11

Month

12

Day

Last modified on

2016

Year

12

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001485