A phase II feasibility trial of TS-1/PSK therapy as adjuvant chemotherapy for gastric cancer with TS-1/CDDP as neoadjuvant chemotherapy.

A phase II feasibility trial of TS-1/PSK therapy as adjuvant chemotherapy for gastric cancer with TS-1/CDDP as neoadjuvant chemotherapy. - A phase II trial of TS-1/PSK therapy for gastric cancer with TS-1/CDDP as neoadjuvant chemotherapy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004266

Enrollment

Registered

2010-10-01

Start date

2010-12-01

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 chemotherapy TS-1: 80mg/m2, Day1-21, p.o.. CDDP: 60mg/m2, Day8. 1 course takes 28 days. As a rule, 2 courses. Adjuvant chemotherapy TS-1: TS-1 administration according to body surf

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gastric Adenocarcinoma 2. Stage3 or curative resectable stage4 3. Treated with S-1 and CDDP as neoadjuvant chemotherapy 4. R0 or R1 resection 5. Age between 20 and 80 6, ECOG performance status of 0 or 1 7. No prior treatment for gastric cancer 8. Major organ function preserved 9. Oral intake possible 10. With written informed consent

Exclusion criteria

Exclusion criteria: 1.Double cancer. 2.Patients with administration contraindication of TS-1. 3.Patients who need continuing use of flucytosine, phenytoin, warfarin potassium. 4.Patients with severe complication (such as ileus, interstitial lung disease, lung fibrosis, diabetes that is difficult to control, heart failure, renal failure, liver failure). 5.Pregnant or lactating patients. 6.Male who have intention that get with child. 7.Patients who are not suitable for this trial by doctor's judgment.

Design outcomes

Primary

Measure	Time frame
1.Adverse event and its frequency 2.Medication compliance (Relative performance: RP%) 3.Recurrence-free survival time and survival time	—

Countries

Japan

Contacts

Public ContactYoshiyuki Fujiwara

Graduate School of Medicine Osaka University Gastroenterological Surgery

yfujiwara@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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