UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037472
Receipt number 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 13:53:00

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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 or person

Institute

Preoperative Serum Glycoproteins Study Group for Immunotherapy in Japan

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

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

Value
https://center6.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