UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037483 |
|---|---|
| Receipt number | 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 11:21:13 |
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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
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
ogoshi@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
The Japanese Society of Strategies for
Cancer Research and Therapy
Institute
Department
Personal name
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
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
Value
https://center6.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 |
