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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007681
Receipt No. 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

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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
Email

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
Email info@troc.jp

Sponsor
Institute Tokyo Radiation Oncology Clinic
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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