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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008097
Receipt No. 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

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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
Email 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
Email immunotherapy-admin@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009529

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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