UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006404 |
|---|---|
| Receipt number | R000007597 |
| Scientific Title | Radiofrequenccy Ablation Combined with Hepatic Arterial Embolization using Degradable Starch Microsphere-MitomycinC for the Treatment of Liver Metastasis from Colorectal cancer. |
| Date of disclosure of the study information | 2011/09/26 |
| Last modified on | 2016/03/24 15:34:36 |
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Basic information
Public title
Radiofrequenccy Ablation Combined with Hepatic Arterial Embolization using Degradable Starch Microsphere-MitomycinC for the Treatment of Liver Metastasis from Colorectal cancer.
Acronym
DRAM study
Scientific Title
Radiofrequenccy Ablation Combined with Hepatic Arterial Embolization using Degradable Starch Microsphere-MitomycinC for the Treatment of Liver Metastasis from Colorectal cancer.
Scientific Title:Acronym
DRAM study
Region
| Japan |
Condition
Condition
Colorectal cancer liver metastasis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness of combination therapy of radiofrequency ablation and hepatic arterial embolization using degradable starch microsphere-mitomycinC in patients with colorectal cancer liver metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Local tumo control
Key secondary outcomes
Adverse effect, local recurrence per lesion, change in tumor marker, Overall survival, 2-year survival rate, local tumor recurrence-free survival, recurrence-free survival, radiological findings.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Radiofrequency ablation will be done after hepatic arterial embolization with degradable starchmicrosphere and mitomycinC. Twenty-five patients with colorectal cancer livr metastasis will be treated and followed for 2 years. Study period will be 36 months.
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) Diagnosis of colorectal liver metastasis is histologically or radiologically established. Patients are not surgical candidates or they decline surgical intervention.
2) Primary lesion is controlled.
3) Liver tumors are 3 or fewer with a maximum diameter of 3cm or smaller or, a single with a maximum diamter of 5cm or smaller.
4) No extraheopatic metastasis or controllable even it exists.
5) Liver tumors are not adjacent to the common bile duct or main portal vein.
6) No bile duct abnormality.
7) Age of 20 years or older.
8) ECOG PS of 0 or 1.
9) At least 4 weeks interval from previous treatments.
10) Function of main organs are well preserved.
11) Infromed consent is given from the patient.
Key exclusion criteria
1) Uncontrollable extrahepatic metastasis.
2) Venous invasion.
3) Artrial-portal or -venous shunting.
4) Hepatic arterial obstruction that may prevent embolization.
5) History of billiary surgery.
6) Tumors are close to the bowel and it is difficult to separate them.
7) Herat failure, Renal failure, and active infection, GI bleeding, double cancers, mental disease.
8) Fever (>38 degree celcius).
9) Allergy to contrast medium or mitomycinC.
10) Pregnant woman or woman who is willing to be pregnant.
11) Other reasons that a primary doctor judges judges as inappropriate for a candidate of thi study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro yamakado |
Organization
Mie University Hospital
Division name
Department of Interventional Radiology
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5029
yama@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruyuki Takaki |
Organization
Mie University Hospital
Division name
Department of Interventional Radiology
Zip code
Address
2-174 Edobashi, Tsu, Mie, Japan
TEL
+81-59-231-5029
Homepage URL
yama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Japanese College of Radiology
Institute
Department
Personal name
Funding Source
Organization
Mie University
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
| 2011 | Year | 09 | Month | 26 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 24 | Day |
Last modified on
| 2016 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007597
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