UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008097 |
|---|---|
| Receipt number | R000009529 |
| Scientific Title | Combination of chemotherapy with docetaxel / cisplatin / fluorouracil (DCF) and autologous gamma/delta T cell transfer therapy for esophageal cancer. |
| Date of disclosure of the study information | 2012/06/04 |
| Last modified on | 2019/04/16 10:59:25 |
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Basic information
Public title
Combination of chemotherapy with docetaxel / cisplatin / fluorouracil (DCF) and autologous gamma/delta T cell transfer therapy for esophageal cancer.
Acronym
DCF and gamma/delta T cell therapy for esophageal cancer.
Scientific Title
Combination of chemotherapy with docetaxel / cisplatin / fluorouracil (DCF) and autologous gamma/delta T cell transfer therapy for esophageal cancer.
Scientific Title:Acronym
DCF and gamma/delta T cell therapy for esophageal cancer.
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the safety of the combination treatment and in vivo dynamics of gamma/delta T cells when DCF and gamma/delta T cells are given together in patients with recurrent or advanced esophageal cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
Efficacy
- Progression-free survival
- Overall survival
- Response rate
- Survival rate (1 and 2 years)
- Response of tumor-related markers
- Immunological responses
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
| Medicine | Maneuver |
Interventions/Control_1
-Docetaxel 60mg/m2 on day1 of each cycle
-Cisplatin 60mg/m2 on day1 of each cycle
-Fluorouracil 600mg/m2/day continuous infusion on days 1 through 5 each cycle
-Autologous gamma/delta T cells on day15, day22.
If after 2 cycles the patients cancer have not responded sufficiently they will be removed from the study. If significant reduction in the size of the tumor is observed after cycle 2.
Treatment can be continued until response is assessed as PD.
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
Recurrent or unresectable advanced esophageal cancer patients who are eligible for DCF chemotherapy and meet the following:
- Pathological Diagnosed of esophageal cancer;
- Diagnosis of recurrent esophageal cancer by imaging;
- Life-expectancy is more than 3 months;
- Performance status is 0-1;
- No serious abnormality in heart, lung, bone marrow, liver, and renal functions.
Key exclusion criteria
Patients who have:
- Pulmonary fibrosis or interstitial pneumonia, including their history or predisposition;
- Treated with chemoradiotherapy;
- Active enteritis;
- Active autoimmune diseases,
- Active infections;
- Other cancers;
- Other serious complications;
- Continuous systemic administration of steroids.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Seto |
Organization
The University of Tokyo Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kakimi |
Organization
The University of Tokyo Hospital
Division name
Department of Immunotherapeutics
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5805-3161
Homepage URL
immunotherapy-admin@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit 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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 04 | 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
| 2012 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 04 | Day |
Last modified on
| 2019 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009529
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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