A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer

A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer - A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer (KUGC07)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004701

Enrollment

110

Registered

2011-02-01

Start date

2011-03-01

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

Stage II or III gastric cancer

Interventions

S-1:80mg/m2 PO bid (morning and evening) for 4 weeks with 2 weeks rest For one year after surgery S-1:80mg/m2 PO bid (morning and evening) for 4 weeks with 2 weeks rest, Hotyu-ekki-to:7.5g/day (2.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Histologically proven gastric cancer (2) pStage II/III (except for T3N0 tumor) after R0 resection (3) Patient with negative peritoneal washing cytology, and without liver metastasis (4) Age 20-80 years old (5) Patient who can start S-1 within 8 weeks after surgery. (6)Adequate organ functions defined as indicated below (i)WBC >= 3,000 /mm3 , WBC <= 12,000 /mm3 (ii)neutrophil >= 1,500 /mm3 (iii)hemoglobin >=9 g/dL (iv)Plt >= 100,000 /mm3 (v) T.Bil <= 1.5 mg/dL (vi) AST(GOT) , ALT(GPT) <= 100 IU/L (vii) Ccr >= 60 mL/min (7) Written informed consent

Exclusion criteria

Exclusion criteria: (1)Patient with active double cancer (synchronous double cancer and metachronous double cancer), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. (2)Patient who was diagnosed as cStage IV at any time during preoperative treatment (3)Patient with administration contraindication of S-1 (4)Patient with regular use of H2-blocker, proton pump inhibitor, flucytosine, phenytoin, or warfarin.(5)Patients with past history of severe allergic reactions. (6)Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, heart failure, renal failure, or liver cirrhosis (7)Severe watery diarrhea. (8)Pregnant or nursing patient or with intent to bear baby (9) Men with partner willing to get pregnant (10)Exclude patients who are recognized as inadequate patients by doctors with responsibility in this trial.

Design outcomes

Primary

Measure	Time frame
completion rate of one year adjuvant treatment with S-1	—

Countries

Japan

Contacts

Public ContactHiroshi Okabe

Graduate School of Medicine, Kyoto University Department of Surgery

hokabe@kuhp.kyoto-u.ac.jp075-366-7595

Outcome results

None listed

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