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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037472
Receipt No. R000042718
Scientific Title Randomized controlled trial to evaluate the effectiveness of immunotherapy in gastric cancer based on preoperative serum glycoproteins: acute phase reactants (APRs).
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 effectiveness of immunotherapy in gastric cancer based on preoperative serum glycoproteins: acute phase reactants (APRs).
Acronym Randomized controlled trial based on preoperative serum glycoproteins (PSGP trial).
Scientific Title Randomized controlled trial to evaluate the effectiveness of immunotherapy in gastric cancer based on preoperative serum glycoproteins: acute phase reactants (APRs).
Scientific Title:Acronym Randomized controlled trial based on preoperative serum glycoproteins (PSGP trial).
Region
Japan

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

Objectives
Narrative objectives1 To predict the effectiveness of PSK immunotherapy for gastric cancer, by analyzing the base line levels of CEA and acute phase reactants: IAP, sialic acid, ASP, ACT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Five year overall survival after gastrectomy according to the combinatory CEA and APRs.
Key secondary outcomes Overall survival according to HLA antigens.

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 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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. Fluoropyrimidine prodru (5-FU 150mg/day or FT (600mg/day or HCFU 400mg/day) was administered orally from 14 days after gastrectomy over 1 year. MMC was injected intravenously 20 mg intraoperatively and/or 10 mg on postoperative day 1.
Interventions/Control_2 CEA(-)APR(-)
CEA(-)APR(+)
CEA(+)APR(-)
CEA(+)APR(+)
Interventions/Control_3 T1: Gastrectomy alone or Gastrectomy + PSK
T2-4: Gastrectomy + MMC + F + PSK
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 Biopsy-proven primary gastric adenocarcinoma patients who gave informed consent.
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 800

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 Preoperative Serum Glycoproteins Study Group for Immunotherapy in Japan
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 Preoperative Serum Glycoproteins Study Group for Immunotherapy in Japan
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 Preoperative Serum Glycoproteins Study Group for Immunotherapy in Japan (PSGP).
https://doi.org/10.4993/acrt1992.7.43

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/acrt1992.7.43 https://doi.org/10.4993/acrt1992.7.109
Publication of results Partially published

Result
URL related to results and publications https://doi.org/10.4993/acrt1992.7.43 https://doi.org/10.4993/acrt1992.7.109
Number of participants that the trial has enrolled 886
Results
PSK therapy has a beneficial effect on gastric cancer patients with high levels of CEA and acute phase reactant (APR).
Results date posted
2019 Year 07 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eight hundred eighty six patients enrolled in this study. Median age (range) was 59 years old (21-88 years old), and male and female, 593 and 293, respectively. 
Participant flow
Eight hundred twenty two patients were assigned to therapy groups as follows; gastrectomy alone 258, PSK 263, MF 150, and MFPSK 151 according to preoperative combinatory CEA and APRs status.

CEA(+)APR(+)
Gastrectomy alone     5 
PSK                  4
MF                   10
MFPSK                17
CEA(+)APR(-)(n=19)
Gastrectomy alone    5
PSK                 6
MF                   5
MFPSK                3
CEA(-)APR(+)(n=180)
Gastrectomy alone   53
PSK                55
MF                  61
MFPSK               56
CEA(-)APR(-)(n=511)
Gastrectomy alone  184
PSK               188
MF                  68
MFPSK               71
Adverse events
See in https://doi.org/10.4993/acrt1992.7.43
Outcome measures
Overall survival
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
1986 Year 11 Month 01 Day
Date of IRB
1986 Year 11 Month 01 Day
Anticipated trial start date
1987 Year 02 Month 01 Day
Last follow-up date
2012 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information PSGP 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=R000042718

Research Plan
Registered date File name

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

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


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