UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000669 |
|---|---|
| Receipt number | R000000804 |
| Scientific Title | Neoadjuvant immunochemotherapy using intratumoral injection of dendritic cells for thoracic esophageal cancers |
| Date of disclosure of the study information | 2007/09/01 |
| Last modified on | 2012/04/03 13:35:24 |
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Basic information
Public title
Neoadjuvant immunochemotherapy using intratumoral injection of dendritic cells for thoracic esophageal cancers
Acronym
Neoadjuvant immunochemotherapy using intratumoral injection of dendritic cells for thoracic esophageal cancers
Scientific Title
Neoadjuvant immunochemotherapy using intratumoral injection of dendritic cells for thoracic esophageal cancers
Scientific Title:Acronym
Neoadjuvant immunochemotherapy using intratumoral injection of dendritic cells for thoracic esophageal cancers
Region
| Japan |
Condition
Condition
Thoracic esophageal cancers
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate safety and efficacy of neoadjuvant immunochemotherapy using intratumoral injection of dendritic cells for thoracic esophageal cancers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Incidence of adverse event
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
intratumoral injection of dendritic cells on day 3 in the 1st course of neoadjuvant 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients are diagnosed as having lymph node metastasis using CT scan and PET scan.
Patients have not received any other treatent for esophageal cancers.
Key exclusion criteria
Patients with serious concomitant disease
Patients with autoimmune disease
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Miyata |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
TEL
Homepage URL
hmiyata@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2007 | Year | 09 | Month | 01 | 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
| 2007 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 04 | Month | 03 | Day |
Last modified on
| 2012 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000804
