UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Percutaneous Radiofrequency ablation for Pulmonary Metastasis from Colorectal Cancer: Phase II Clinical Trial
Title of the study (Brief title)	SCIRO-1401 study
Region	Japan

Condition
Condition	Pulmonary metastasis from colorectal cancer
Classification by specialty	Gastroenterology Pneumology Gastrointestinal surgery Chest surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To prospectively evaluate the outcomes of radiofrequency ablation (RFA) for pulmonary metastases from colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	3-year overall survival
Key secondary outcomes	1- and 5-year overall survival, Adverse events, Local tumor control, Cause-specific survival, Relapse-free survival

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	Lung Radiofrequency Ablation
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	1) (a)Colorectal cancer patients in whom primary lesion is controlled. (b)Patients who have pulmonary metastasis diagnosed clinically and radiologically. (c)Absence of viable extrapulmonary metastasis. (d)All of the pulmonary metastases is considered to be treatable with RFA. 2)Pulmonary metastases with the number of less than 6 and long axis diameter of smaller than 3.0cm. 3)No disfunction of major organs.
Key exclusion criteria	1)Lack of safe needle insertion path. 2)RFA is considered to be de hazardous because of critical organs close to the target lesion. 3)Presence of sever comorbidities. 4)Presence of uncontrolled other malignant diseases. 5)Presence of peritoneal dissemination and/or malignant ascites. 6)Fever higher than 38-Celsius degree. 7)Severe impairment of contralateral pulmonary function. 8)Presence of pulmonary hypertension. 9)Presence of interstitial pneumonia. 10)Usage of anticoagulants and antiplatelet agents. 11)Pregnant patients. 12)Patients who are considered to be unsuitable for inclusion by physicians due to other reasons.
Target sample size	45

Research contact person
Name of lead principal investigator	Susumu Kanazawa
Organization	Okayama University Medical School
Division name	Department of Radiology
Address	2-5-1 Shikatacho, Kita-ku, Okayama, Japan
TEL	086-235-7313
Email	susumu@cc.okayama-u.ac.jp

Public contact
Name of contact person	Yusuke Matsui
Organization	Okayama University Medical School
Division name	Department of Radiology
Address	2-5-1 Shikatacho, Kita-ku, Okayama, Japan
TEL	086-235-7313
Homepage URL
Email	wckyh140@yahoo.co.jp

Sponsor
Institute	Department of Radiology, Okayama University Medical School
Institute
Department

Funding Source
Organization	Department of Radiology, Okayama University Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	2014 Year 06 Month 27 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 17 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2018 Year 01 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 06 Month 26 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016066