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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037475
Receipt No. R000042721
Scientific Title Randomized controlled trial to evaluate the prediction of the effectiveness for HLA-oriented therapy in gastric and colorectal cancer.
Date of disclosure of the study information 2019/07/29
Last modified on 2019/07/24

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Basic information
Public title Randomized controlled trial to evaluate the prediction of the effectiveness for HLA-oriented therapy in gastric and colorectal cancer.
Acronym Randomized controlled trial to evaluate the prediction of the effectiveness for HLA-oriented therapy (JCTB trial).
Scientific Title Randomized controlled trial to evaluate the prediction of the effectiveness for HLA-oriented therapy in gastric and colorectal cancer.
Scientific Title:Acronym Randomized controlled trial to evaluate the prediction of the effectiveness for HLA-oriented therapy (JCTB trial).
Region
Japan

Condition
Condition Gastric cancer
Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Prediction of PSK immunotherapy response in patients with HLA B40 or B51.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Five year overall survival after gastrectomy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 HLA B40(+)
HLA B51(+)
Interventions/Control_2 PSK(-)
PSK(+):
PSK was administered orally from 14 days after gastrectomy at a dose of 3.0g/day and at least at a dose of over 270g. Per os fluoropyrimidine prodru (5-FU 150mg/day or UFT (300mg/day) was administered orally from 14 days after gastrectomy over 1 year. MMC was injected intravenously 0.4 mg/Kg intraoperatively and/or 0.2 mg/Kg on postoperative day 1.
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 Primary T2-T4 gastric and colorectal cancer patients who gave informed consent.
MMC injection and the selection of F drugs was depended on an attending doctor.
Key exclusion criteria 1. Double cancer.
2. Prior cytotoxic or radiation therapy.
3. Abnormal bone marrow, hepatic and renal function
4. Severe cardiac, hepatic and lung failure, and an attending doctor was considered unsuitable.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Kaichi
Middle name
Last name Isono
Organization Chiba University
Division name Department of Surgery
Zip code 263-8522
Address 1-33 Yayoichou, Inageku , Chiba, 263-8522, Japan
TEL 043-251-1111
Email iso2218@clock.ocn.ne.jp

Public contact
Name of contact person
1st name Kyoji
Middle name
Last name Ogoshi
Organization Tokai University
Division name Department of Surgery
Zip code 259-1193
Address Bohseidai, Isehara, Kanagawa 259-1193, Japan.
TEL 0463-96-6163
Homepage URL
Email ogoshi@is.icc.u-tokai.ac.jp

Sponsor
Institute Japan cancer treatment and behavior study group(JCTB)
Institute
Department

Funding Source
Organization Daiichi Sankyo Company
Kureha Chemical Industry
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan cancer treatment and behavior study group(JCTB)
Address 1-33 Yayoichou, Inageku , Chiba, 263-8522, Japan
Tel 043-251-1111
Email iso2218@clock.ocn.ne.jp

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
2019 Year 07 Month 29 Day

Related information
URL releasing protocol https://doi.org/10.4993%2Facrt.12.87
Publication of results Partially published

Result
URL related to results and publications https://doi.org/10.4993%2Facrt.12.87
Number of participants that the trial has enrolled 432
Results
We failed to confirm that HLA B40 and  B51 antigens significantly associated with response to PSK therapy.
Results date posted
2019 Year 07 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Four hundred thirty two patients enrolled in this study. In gastric cancer, median age (range) was 60 years old (25-86 years old), and male and female, 230 and 93, respectively, and in colon cancer 63 years old (36-90 years old) and 57 and 52, respectively.
Participant flow
Four hundred fourteen patients were assigned to therapy groups according to HLA B40 and B51 as follows;

        Gastric cancer    Colon cancer
B40(+) MF  48 MFPSK  50  MF 20  MFPSK 17
B51(+) MF  32 MFPSK  25  MF  6  MFPSK  6
B40(-) MF 110 MFPSK  97  MF 41  MFPSK 30
B51(-) MF 126 MFPSK 122  MF 55  MFPSK 41
Adverse events
not particular
Outcome measures
Overall survival
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
1990 Year 10 Month 01 Day
Date of IRB
1990 Year 10 Month 01 Day
Anticipated trial start date
1990 Year 12 Month 01 Day
Last follow-up date
2012 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information JCTB Research board discussed our research protocol based on the principles outlined in the Declaration of Helsinki.

Management information
Registered date
2019 Year 07 Month 24 Day
Last modified on
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042721

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/07/25 JCTB UMIN胃大腸登録.xlsx


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