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The Effect of Preoperative PSK therapy in Advanced gastric cancer (pilot trial)

The Effect of Preoperative PSK therapy in Advanced gastric cancer (pilot trial) - Preoperative PSK therapy in Advanced gastric cancer (pilot trial)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006025
Enrollment
40
Registered
2011-07-22
Start date
2009-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

Neoadjuvant PSK therapy (-) Adjuvant Chemotherapy Tegafur/gimeracil/oteracil potassium (S-1) plus Krestin (PSK) Drug:Tegafur-gimeracil-oteracil potassium (TS-1) 80 mg/m2, PO from day 1 to da

Sponsors

Kitazato University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Stage I-III stomach cancer before surgery 2. Patient whose age at the registration is ranging between 20 and 80 years old 3. Patient who has not received any preoperative therapy including radiotherapy, chemotherapy and immunotherapy 4. Patient with metachronous or synchronous multicancer 5. Patient who has no serious concurrent complications, and satisfies the following criteria  Patient who has no diarrhea (watery stool)  White blood cell count is more than 4,000 /mm3 and less than 12,000 /mm3  Neutrophil count is more than 2,000 /mm3  Platelet count is more than 100,000 /mm3  Amount of hemoglobin is more than 9.0g/dL  Serum AST (GOT), ALT (GPT) is less than 100IU/L  Serum total bilirubin is less than 1.5 mg/dL  Serum creatinine is less than 1.5 mg/dL 6. ECOG performance status of 0 - 2 7. Patient who has received an explanation of this study by assent documents, and has given written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1. Patient with bleeding from gut 2. Patient with severe fluid retention 3. Patient with infection, paralysis of intestine and ileus. 4. Patient who is pregnant or in lactation, or wish to become pregnant during this study 5. Patient with treatment of insulin or uncontrollable diabetes mellitus. 6. Patient with heart insufficiency 7. Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study 8. Patients receiving continuous administration of steroids 9. Patient who has experienced serious drug allergy in the past 10. Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge

Design outcomes

Primary

MeasureTime frame
TGF-beta

Secondary

MeasureTime frame
CEA,CA19-9,General hematological examination,General biochemical examination

Countries

Japan

Contacts

Public ContactYamashita Keishi

Kitazato University, School of Medicine Surgery

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026