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 |
Randomized controlled trial to evaluate the effectiveness of immunotherapy in gastric cancer based on preoperative serum glycoproteins: acute phase reactants (APRs).
Randomized controlled trial based on preoperative serum glycoproteins (PSGP trial).
Randomized controlled trial to evaluate the effectiveness of immunotherapy in gastric cancer based on preoperative serum glycoproteins: acute phase reactants (APRs).
Randomized controlled trial based on preoperative serum glycoproteins (PSGP trial).
Japan |
Gastric cancer
Gastrointestinal surgery |
Malignancy
YES
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.
Efficacy
Five year overall survival after gastrectomy according to the combinatory CEA and APRs.
Overall survival according to HLA antigens.
Interventional
Parallel
Randomized
Cluster
Double blind -all involved are blinded
Active
YES
Institution is not considered as adjustment factor.
Central registration
3
Treatment
Medicine |
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.
CEA(-)APR(-)
CEA(-)APR(+)
CEA(+)APR(-)
CEA(+)APR(+)
T1: Gastrectomy alone or Gastrectomy + PSK
T2-4: Gastrectomy + MMC + F + PSK
20 | years-old | <= |
Not applicable |
Male and Female
Biopsy-proven primary gastric adenocarcinoma patients who gave informed consent.
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.
800
1st name | Kaichi |
Middle name | |
Last name | Isono |
Chiba University
Department of Surgery
263-8522
1-33 Yayoichou, Inageku , Chiba, 263-8522, Japan
043-251-1111
iso2218@clock.ocn.ne.jp
1st name | Kyoji |
Middle name | |
Last name | Ogoshi |
Tokai University
Department of Surgery
259-1193
Bohseidai, Isehara, Kanagawa 259-1193, Japan
0463-96-6163
ogoshi@is.icc.u-tokai.ac.jp
Preoperative Serum Glycoproteins Study Group for Immunotherapy in Japan
Daiichi Sankyo Company
Kureha Chemical Industry
Profit organization
Preoperative Serum Glycoproteins Study Group for Immunotherapy in Japan
1-33 Yayoichou, Inageku , Chiba, 263-8522, Japan
043-251-1111
iso2218@clock.ocn.ne.jp
NO
Preoperative Serum Glycoproteins Study Group for Immunotherapy in Japan (PSGP).
https://doi.org/10.4993/acrt1992.7.43
2019 | Year | 07 | Month | 29 | Day |
https://doi.org/10.4993/acrt1992.7.43 https://doi.org/10.4993/acrt1992.7.109
Partially published
https://doi.org/10.4993/acrt1992.7.43 https://doi.org/10.4993/acrt1992.7.109
886
PSK therapy has a beneficial effect on gastric cancer patients with high levels of CEA and acute phase reactant (APR).
2019 | Year | 07 | Month | 24 | Day |
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.
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
See in https://doi.org/10.4993/acrt1992.7.43
Overall survival
Completed
1986 | Year | 11 | Month | 01 | Day |
1986 | Year | 11 | Month | 01 | Day |
1987 | Year | 02 | Month | 01 | Day |
2012 | Year | 01 | Month | 31 | Day |
PSGP Research board discussed our research protocol based on the principles outlined in the Declaration of Helsinki.
2019 | Year | 07 | Month | 24 | Day |
2019 | Year | 07 | Month | 24 | Day |
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 |