UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037475 |
|---|---|
| Receipt number | 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 | 2023/04/13 11:32:13 |
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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
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
Japan cancer treatment and behavior study group(JCTB)
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/acrt/29/2/29_135/_article/-char/ja
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
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.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 |
