Phase I/II study of biweekly docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy in patients with stage III gastric cancer

Phase I/II study of biweekly docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy in patients with stage III gastric cancer - Phase I/II study of biweekly docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy in patients with stage III gastric cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011625

Enrollment

Registered

2013-09-02

Start date

2013-09-02

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

Docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy Docetaxel: 20mg/m2 day1,15 CDDP: 25-50mg/m2 day1,15 TS-1: 80mg/m2 day1-7, 15-21

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologic confirmation of gastric cancer 2. Stage III with no peritoneal meastases and CY0 by dagnostic laparoscopy 3. Patient expected R0 resection at the registration 4. Performance status (ECOG scale) 0 or 1 5. No prior chemotherapy 6. Adequate baseline organ and marrow function from data within 14 days before registration WBC count >=3,000/mm3,<=12,000/mm3 Neutorophil count>=1,500/mm3 Hemoglobin>=9.0g/dl Platelet count>=100000/mm3 AST,ALT<= 2.5 times the upper limit of normal Al-P<=2.5 times the upper limit of normal Total bilirubin<=1.5 mg/dl serum creatinin level<=1.5 mg/dl Blood urea nitrogen within normal range 7. Patients who can take food orally 8. Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1. with active double cancer within 5 years except intramucosal cancer 2. with a history of severe allergy 3. with active infectious disease(over 38 degrees C) 4. Women in pregnancy, at risk of pregnancy, or hoping to become pregnant. 5. Men who want their partners to become pregnant 6. with a history of cardiac infarction in recent 6 months 7. with a continuous administration of steroids 8. patient who needs continuous administration of Flucytosine, fenitoin or walfarin karium 9. with ulceration on digestive tract and/or bleeding from the ulcer 10. with uncontrollable diarrhea or watery stool 11. with active hepatitis B Ag and/or hepatitis C Ab 12. with serious complication as followings, -Interstitial pneumonia -Pulmonary fibrosis -paralysis on bowel -ischemic heart diseases 13. Any patients judged by the investigator to be unfit to participate in the study

Design outcomes

Primary

Measure	Time frame
Phase I : Feasibility of the regimen followed by decision of recommend dose Phase II : Response rate, Overall survival, Adverse events	—

Countries

Japan

Contacts

Public ContactYusuke Izumisawa

Yokohama City University Medical Center Gastroenterological Center

ycu.umin@gmail.com045-261-5656

Outcome results

None listed

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