UMIN-CTR Clinical Trial

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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