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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014391
Receipt No. R000016066
Scientific Title Percutaneous Radiofrequency ablation for Pulmonary Metastasis from Colorectal Cancer: Phase II Clinical Trial
Date of disclosure of the study information 2014/06/27
Last modified on 2018/01/26

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Basic information
Public title Percutaneous Radiofrequency ablation for Pulmonary Metastasis from Colorectal Cancer: Phase II Clinical Trial
Acronym SCIRO-1401 study
Scientific Title Percutaneous Radiofrequency ablation for Pulmonary Metastasis from Colorectal Cancer: Phase II Clinical Trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Susumu Kanazawa
Organization Okayama University Medical School
Division name Department of Radiology
Zip code
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
1st name
Middle name
Last name Yusuke Matsui
Organization Okayama University Medical School
Division name Department of Radiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Terminated
Date of protocol fixation
2014 Year 06 Month 17 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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