Docetaxel and S-1 as adjuvant chemotherapy for pathological stage II, IIIA, IIIB gastric cancer

Docetaxel and S-1 as adjuvant chemotherapy for pathological stage II, IIIA, IIIB gastric cancer - Docetaxel and S-1 as adjuvant chemotherapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000857

Enrollment

Registered

2007-10-19

Start date

2007-06-01

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

Pathological stage II, IIIa, or IIIb gastric cancer

Interventions

Docetaxel(40mg/m2, day1), S-1(80mg/m2, day1-14) combination therapy, every 3 weeks, 4 cycles followed by S-1(80mg/m2, day1-14) monotherapy every 3 weeks until 1 year from surgery.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed Gastric cancer 2. Curatively resected gastric cancer(R0 surgery) with D2 lymph-node resection 3. Pathlogical Stage II, IIIA, IIIB 4. No prior chemotherapy for current disease. 5. Sufficient organ function (within 2 weeks before enrollment) 6. ECOG performance status 0-1. 7. Age &#8805;20 and <80 years old 8. Maximum of 8 weeks since surgery and patients who can take medicine orally. 9. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. 2. Contraindication to S-1 3. Under treatment with flucytosine, phenytoin, or warfarin 4. Past history of severe drug hypersensitivity. 5. Uncontrolled medical conditions (e.g., Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray, malignant hypertension, congestive heart failure, myocardial infarction in previous 6 months, arrhythmia requiring treatment, hemorrhage, diabetes). 6. Hepatitis B/C 7. Diarrhea 8. Pregnant or lactating women and women of child bearing potential not using contraception 9. Severe peripheral edema. 10. Grade 2 or greater peripheral neuropathy. 11. HIV positive. 12. Patients judged by the investigator as unfit to be enrolled in the study.

Design outcomes

Primary

Measure	Time frame
Feasibility of Docetaxel+S-1 4 cycles	—

Secondary

Measure	Time frame
Feasibility of Docetaxel+S-1 4 cycles followed by S-1 alone for 1 year, Safety	—

Countries

Japan

Contacts

Public ContactYoshihiro Kakeji

Kyushu University Dept. of Surgery and Science

Outcome results

None listed

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