UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001168 |
|---|---|
| Receipt number | R000001390 |
| Scientific Title | Phase I/II study of transcatheter arterial chemo-embolization with DDP-H and degradable starch microspheres for hepatic metastases of colorectal cancer |
| Date of disclosure of the study information | 2008/06/02 |
| Last modified on | 2010/07/13 22:49:30 |
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Basic information
Public title
Phase I/II study of transcatheter arterial chemo-embolization with DDP-H and degradable starch microspheres for hepatic metastases of colorectal cancer
Acronym
Phase I/II study of transcatheter arterial chemo-embolization with DDP-H and degradable starch microspheres for hepatic metastases of colorectal cancer
Scientific Title
Phase I/II study of transcatheter arterial chemo-embolization with DDP-H and degradable starch microspheres for hepatic metastases of colorectal cancer
Scientific Title:Acronym
Phase I/II study of transcatheter arterial chemo-embolization with DDP-H and degradable starch microspheres for hepatic metastases of colorectal cancer
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Owing to hepatic lesion as a conceivable important prognostic factor, we evaluate the efficacy and the safety of DDP-H and DSM treatment for hepatic metastases of unresectable colorectal cancer patients, who were given the standard treatment along with colorectal cancer treatment guideline, with dose limiting factor (DLT) , recommendation dose (RD) and recommendation total dose of view.
Basic objectives2
Others
Basic objectives -Others
Early therapy response using MRI(DWI)
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Dose Limiting Toxicity,Recommended Dose
Key secondary outcomes
Adverse events, Response rate, Overall survival, Progression 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
| Medicine |
Interventions/Control_1
The protocol in the clinical trial repeatedly makes up treatment couses which is constituted DPP-H and DSM mixing solution injects into hepatic artery until the embolization appears conducts every 4 weeks.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed colorectal carcinoma with unresectable liver metastases.
2. Metastatic hepatic lesion as the most prior prognostic factor.
3. Refractory with standard chemotherapy or contraindication of chemotherapy. No history of chemotherapy 2 weeks before.
4. Existing measurable hepatic lesion Response Evaluation Criteria in Solid Tumor (RECIST) is applicable (More than two times thickness slice resolution with CT).
5. Performance Status (ECOG): 0,1,2
6. Adequate organ functions: bone marrow, Heart, renal function (2 weeks before entry)
WBC: 3000/mm3-12000/mm3
Plt: >=7.5x104/mm3
T-Bil: <=2.5mg/dl
Serum Cre: <=1.5mg/dl
BUN: <=25mg/dl
PT: >=50%
7. Age: 20 to 80 yrs
8. Expected survival time over 8 weeks
9. Written informed consent
Key exclusion criteria
1) Reconstruction of the biliary tract history
2) Severe complication (Cardiac failure, Myocardial infarction, Pulmonary fibrosis, Interstitial pneumonia, Uncontrollable diabetic, Renal failure)
3)Active infection (Hepatitis C virus is permitted)
4) Active double cancer
5) Hyper sensitivity history with iodin contrast medium or platinum related substance, or starch 6) Pregnant, nursing or possible pregnant woman
7) Heparic artery occlusion under CT angiography or angiography (Registration after qualification with CT angiography. Judging occlusion under angiography, including reservoir DAS, in case unqualified judgement with CT angiography) 8) Qualified ineligible patients being this clinical trial by responsible doctor
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Tanaka |
Organization
Nara Medical University Hospital
Division name
Radiology
Zip code
Address
840 Sijo-cho,kashihara-city,Nara,Japan
TEL
0744-29-8900
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Nishiofuku |
Organization
Nara Medical University Hospital
Division name
Radiology
Zip code
Address
840 Sijo-cho,kashihara-city,Nara,Japan
TEL
0744-29-8900
Homepage URL
hmn@naramed-u.ac.jp
Sponsor or person
Institute
Radiology, Nara Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Radiology, Nara Medical University Hospital
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
| 2008 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 05 | Month | 31 | Day |
Last modified on
| 2010 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001390
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