UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007681 |
|---|---|
| Receipt number | R000009060 |
| Scientific Title | Study on adverse effect and efficacy of a human chemokine derivative in combination with radiotherapy for advanced or metastatic malignancy |
| Date of disclosure of the study information | 2012/04/07 |
| Last modified on | 2012/10/09 13:45:43 |
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Basic information
Public title
Study on adverse effect and efficacy of a human chemokine derivative in combination with radiotherapy for advanced or metastatic malignancy
Acronym
Study on adverse effect and efficacy of eMIP in combination with radiotherapy
Scientific Title
Study on adverse effect and efficacy of a human chemokine derivative in combination with radiotherapy for advanced or metastatic malignancy
Scientific Title:Acronym
Study on adverse effect and efficacy of eMIP in combination with radiotherapy
Region
| Japan |
Condition
Condition
Advanced or metastatic malignancy
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of adverse effect and efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Tumor size on CT
(at pretreatment and 2 weeks after treatment)
Evaluation of DLT(dose limiting toxicity)
Key secondary outcomes
Laboratory data(at pretreatment and 2 weeks after treatment)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eMIP
ECI301 50 microgram/kg
Interventions/Control_2
eMIP
ECI301 100 microgram/kg
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
Aged over 20
ECOG PS is equal and less than 2
Expected prognosis is over 3 months
Histologically proven
Metastatic or advanced malignancy(irradiated leion is equal and less than 2)
Targets are measurable
Appropriate function of bone marrow and liver
Recently have a myocardial infarction or tonsilitis, and so on
Key exclusion criteria
In pregnancy or during lactation
Received steroid hormone now
Medication with chemotherapy, radiotherapy, hormone therapy or immunotherapy in the last 4 weeks
Autoimmune disease
Organ transplantation
HIV, hepatitis B/C
Uncontrorable complication
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Kashihara |
Organization
Tokyo Radiation Oncology Clinic
Division name
radiology
Zip code
Address
3-5-7 Ariake Koto Ward, Tokyo
TEL
03-3529-5420
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Kashihara |
Organization
Tokyo Radiation Oncology Clinic
Division name
radiology
Zip code
Address
3-5-7 Ariake Koto Ward, Tokyo
TEL
03-3529-5420
Homepage URL
http://www.troc.jp
info@troc.jp
Sponsor or person
Institute
Tokyo Radiation Oncology Clinic
Institute
Department
Personal name
Funding Source
Organization
ECI Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01441115
Org. issuing International ID_1
NIH/NCI
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京放射線クリニック(東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 07 | Day |
Related information
URL releasing protocol
http://www.troc.jp
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
| 2012 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 06 | Day |
Last modified on
| 2012 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009060
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
