UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028542 |
|---|---|
| Receipt number | R000032668 |
| Scientific Title | A prospective study about efficacy and safety of selective arterial injection chemotherapy for ineffective or intorelable to the standard chemotherapy in advanced esophageal cancer |
| Date of disclosure of the study information | 2017/08/05 |
| Last modified on | 2017/08/04 22:45:43 |
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Basic information
Public title
A prospective study about efficacy and safety of selective arterial injection chemotherapy for ineffective or intorelable to the standard chemotherapy in advanced esophageal cancer
Acronym
A prospective study of selective arterial injection chemotherapy for limited advanced esophageal cancer
Scientific Title
A prospective study about efficacy and safety of selective arterial injection chemotherapy for ineffective or intorelable to the standard chemotherapy in advanced esophageal cancer
Scientific Title:Acronym
A prospective study of selective arterial injection chemotherapy for limited advanced esophageal cancer
Region
| Japan |
Condition
Condition
Esophagus
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safty of selective arterial injection chemotherapy for advanced esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tumor regression effect
Key secondary outcomes
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
| Maneuver |
Interventions/Control_1
selective arterial injection chemotherapy
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)Neoadjuvant chemotherapy for advanced esophageal cancer
2)Cases of ineffective for first FP chemotherapy(SD,PD)
3)Cases of intolerable for other therapies
4)Cases of impossible for other therapies
Key exclusion criteria
1)Impossible for catheter treatment
2)below 20 years old
3)pregnant
4)No informed consent
5)Inappreciate patients
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiro Inoue |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Diseases Center
Zip code
Address
5-1-38,Toyosu, Koto-ku, Tokyo
TEL
03-6204-6000
haruinoue777@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Onimaru |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Diseases Center
Zip code
Address
5-1-38,Toyosu, Koto-ku, Tokyo
TEL
03-6204-6000
Homepage URL
mnbonmr0827@gmail.com
Sponsor or person
Institute
Showa University Koto Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University Koto Toyosu Hospital
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
| 2017 | Year | 08 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 04 | Day |
Last modified on
| 2017 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032668
