UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024322 |
|---|---|
| Receipt number | R000028013 |
| Scientific Title | Prospective study of safety and usefulness of transcatheter arterial chemo- embolization by miriplatin and lipiodol for thoracic malignant tumors |
| Date of disclosure of the study information | 2016/10/11 |
| Last modified on | 2019/10/02 11:26:51 |
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Basic information
Public title
Prospective study of safety and usefulness of transcatheter arterial chemo- embolization by miriplatin and lipiodol for thoracic malignant tumors
Acronym
Transcatheter arterial chemo- embolization by miriplatin and lipiodol for thoracic malignant tumors
Scientific Title
Prospective study of safety and usefulness of transcatheter arterial chemo- embolization by miriplatin and lipiodol for thoracic malignant tumors
Scientific Title:Acronym
Transcatheter arterial chemo- embolization by miriplatin and lipiodol for thoracic malignant tumors
Region
| Japan |
Condition
Condition
Thoracic malignant tumors
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
| Adult | Child |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to examine the tumor response rate and safety of arterial infusion of miriplatin and lipiodol for thoracic malignant tumors, which are difficult to treat by surgery, radiationtherapy, and general chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Tumor response rate and complications
Key secondary outcomes
Local control period and overall survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Thoracic malignant tumros which can be treated by transcatheter arterial chemo- embolization.
2. The patients who are difficult to be treated by surgery, radiotherapy, and chemotherapy.
3. The patients who are not expected by transcatheter arterial embolization.
4. The patients who meet all of those condisitons.
Or the operable patients who are judged to be better treated by transcatheter arterial chemo-embolization for decreasing tumors before surgery
Key exclusion criteria
1. The patients without inclusion criteria.
2. The patients with allergy for blood vessel contrast medium.
3. The patients with renal failure.
4. The patients who are judged to be unsuitable by doctors.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nomori |
Organization
Kameda Medical Center
Division name
Thoracic surgery
Zip code
Address
929 Higashicho, Kamogawa CIty, Chiba
TEL
0470-92-2211
hnomori@qk9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nomori |
Organization
Kameda Medical Center
Division name
Thoracic surgery
Zip code
Address
929 Higashicho, Kamogawa CIty, Chiba
TEL
0470-92-2211
Homepage URL
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
None of the research fund
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 10 | Month | 11 | 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
| 2016 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There is no other informations.
Management information
Registered date
| 2016 | Year | 10 | Month | 06 | Day |
Last modified on
| 2019 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028013
