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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037483
Receipt No. R000042730
Scientific Title Randomized controlled trial to evaluate the prediction of the immunotherapy response based on HLA-type.
Date of disclosure of the study information 2019/07/29
Last modified on 2019/07/25

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Basic information
Public title Randomized controlled trial to evaluate the prediction of the immunotherapy response based on HLA-type.
Acronym Randomized controlled trial of HLA type-oriented therapy (JSCT trial).
Scientific Title Randomized controlled trial to evaluate the prediction of the immunotherapy response based on HLA-type.
Scientific Title:Acronym Randomized controlled trial of HLA type-oriented therapy (JSCT trial).
Region
Japan

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

Objectives
Narrative objectives1 1. Evaluation of overall survival in patients given therapies with or without PSK based on HLA phenotypes.
2. Our hypothesis was that if a new patient who has an identical or similar HLA profile as another patient who has survived for a long time is given the same treatment or drug, that new patient might also survive for a long time.
3. Establishment of HLA oriented therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of overall survival and QOL in patients given therapies with or without PSK based on HLA category types.
Key secondary outcomes Evaluation of overall survival and QOL based on HLA category types in gastric and colorectal cancer.

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 Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 R0:
Gastrectomy alone
Chemotherapy: F/MF
PSK group: F/MF and PSK
R(+)
Chemotherapy: MF/CF
PSK group: MF/CF and 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. Fluoropyrimidine prodrug (5-FU 150mg/day or UFT (300mg/day or TS1 40-80mg/day) was administered orally from 14 days after gastrectomy over 1 year. MMC was injected intravenously 0.4 mg/Kg and/or 0.2 mg/Kg intraoperatively
within 1 month after gastrectomy. CDDP (40-60mg/m2/W 4 times) was administered intravenously after gastrectomy starting from July 1996.
Interventions/Control_2 PSK(-)
PSK(+)
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
81 years-old >
Gender Male and Female
Key inclusion criteria Primary advanced gastric and colorectal cancer patients who gave informed consent and received the examination of HLA. MMC injection (dose and frequency) and the selection of F drugs was depended on an attending doctor
Key exclusion criteria 1. Double cancer.
2. Mucosal and no lymph node metastasis.
3. Prior cytotoxic or radiation therapy.
4. Abnormal bone marrow, hepatic and renal function
5. 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 The Japanese Society of Strategies for
Cancer Research and Therapy
Institute
Department

Funding Source
Organization Self-funding
The Japanese Society of Strategies for
Cancer Research and Therapy
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Japanese Society of Strategies for Cancer Research and Therapy
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 http://joi.jlc.jst.go.jp/JST.JSTAGE/acrt/19.44?from=CrossRef
Publication of results Partially published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/acrt/16/2/16_2_36/_article http://joi.jlc.jst.go.jp/JST.JSTAGE/
Number of participants that the trial has enrolled 542
Results
Our results showed that it is beneficial to examine HLA antigens preoperatively. We observed long term survivors who were given effective therapy, whereas those who died shortly after gastrectomy were given ineffective therapy. We, however, failed to find a specific HLA profile to treatment response. 
 
Results date posted
2019 Year 07 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Five hundred forty two patients were enrolled and assigned 487 (439 gastric cancers and 48 colorectal cancers) to therapies as follows: gastrectomy alone, F, FPSK, MF, MFPSK, CF and CFPSK). Male and female 378 and 164, respectively and median age (range) was 60 years old (23-80 years old). 

Participant flow
          Gastric cancer Colon cancer 
Resectio       122           9                 
Chemotherapy   159          32                 
     F          34           4
     MF        113          14 
     CF         12          14
PSK            167          21                
     F          42           5
     MF        113          16     
     CF         12           0
No assignment   55           0
   
Adverse events
not reported
Outcome measures
Overall survival
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
1992 Year 07 Month 21 Day
Date of IRB
1992 Year 07 Month 21 Day
Anticipated trial start date
1992 Year 08 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 Clinical research for evaluation the prediction of the effectiveness of PSK therapy based on HLA and APRs started in 1977 at the Department of Surgery at Tokai University and continued in PSGP, JCTB and JSCT which were organized by Prof. K. Isono and the summary of the results reported (Ann. Cancer Res. Therap. Vol. 19, No. 2, 44-53, 2011.).
This study was conducted in accordance with the Declaration of Helsinki, and approved by JSCT ethics committees. Our Ethical Guideline was reported in WWaves 9,58-69 2003.

Management information
Registered date
2019 Year 07 Month 25 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042730

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/07/25 JSCT UMIN登録.xlsx


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