Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer

Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer - Feasibility study of adjuvant chemotherapy with TS-1 followed by DCS (DTX+CDDP+S-1) for stage III gastric cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012785

Enrollment

Registered

2014-01-08

Start date

2013-06-24

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

1st course (S-1 alone): S-1 80mg/m2 d1-14, q3w Treatment consisted of 2nd and 3rd courses of S-1 (80 mg/m2/day, b.i.d.) for 14 days followed by a 7-day rest. Docetaxel (35 mg/m2 iv) and Cisplatin (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histopathologically proven gastric cancer (2) D2 lymph-node dissection woti R0 surgery (3) Patients with StageIIIA, StageIIIB or StageIIIC gastric cancer (4) No previous treatment (chemotherapy, radootherapy) for any cancer (5) ECOG performance status 0 or 1. (6) 20 years of age and older (7) Patients who can take medecine orally (8) Without any other severe diseases WBC: 3,500 - 12,000 /mm3 ANC: > 2,000 /mm3 Hgb: > 9.0 g/dL Platelets: > 100,000 /mm3 total bilirubin: < 1.5xULN Total bilirubin: < 1.5xULN AST and ALT: < 2.5xULN Creatinine: < 1.2 mg/dL (9)Written informed consent

Exclusion criteria

Exclusion criteria: (1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma, and multicentric cancer. (2) Patients who are contraindicated to S-1, CDDP, and DTX. (3) Patient is taking flucytosine and phenytoin. (4) Patients with the history of severe drug hypersensitivity. (5) Patients with severe complication (intestinal paralysis, intestinal obstruction, interstitial pneumonitis, pulmonary fibrosis, severe diabetes, heart failure, renal failure, liver cirrhosis, liver failure, etc.). (6) Patients with diarrheal disease or watery diarrhea. (7) Pregnant and/or nursing women (8) Patients with positive HBs antigen (9) Any subject judged by the investigator to be unfit for any reason to participate in the study.

Design outcomes

Primary

Measure	Time frame
Treatment completion rate after 2 cycle of S-1, DTX plus CDDP	—

Secondary

Measure	Time frame
Overall Survival, Relapse Free Survival, Completion rate of S-1 for 1year, Safety	—

Countries

Japan

Contacts

Public ContactNoriyuki Hirahara, M.D., Ph.D.

Shimane University Hospital Digestive and General Surgery

norinori@med.shimane-u.ac.jp0853-20-2232

Outcome results

None listed

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