UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014391 |
|---|---|
| Receipt number | 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 14:17:17 |
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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
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
wckyh140@yahoo.co.jp
Sponsor or person
Institute
Department of Radiology, Okayama University Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016066
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