A phase II study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.

A phase II study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer. - A phase II study of combination Docetaxel, Cisplatin, and S-1 as neoadjuvant chemotherapy for advanced gastric cancer.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000801

Enrollment

Registered

2007-08-15

Start date

2007-01-01

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

advanced gastric cancer

Interventions

Docetaxel 60 mg/m2 1-hour IV day 8 Cisplatin 60 mg/m2 1-hour IV day 8 S-1 80 mg/m2 PO BID days 1-14

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Histologically or cytologically confirmed adenocarcinoma of the stomach 3. T2N1-3M0 in type IV or T3-4 N0-3 M0 in any types 4. Curative resection possible by image diagnosis 5. Measurable lesions according to RECIST guidelines. 6. No prior therapy including surgery, radiotherapy or chemotherapy for current disease. 7. No obvious hemorrhage or obstruction 8. Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions. Hb _ 9.0 g/dL WBC 4.0_1.2 x 109/L, ANC _ 2.0 x 109/L Platelets _ 100 x 109/L AST (SGOT) and ALT (SGPT) _ 100 U/I Total bilirubin _ 1.5mg/dL Serum creatinine _ UNL Creatinine clearance _ 60mL/min 9. ECOG performance status 0-1 10. Life expectancy over 3 months 11. Age _20 and <75 years old 12. Patients who can take medicine orally

Exclusion criteria

Exclusion criteria: 1. A history of hypersensitivity reaction to drugs formulated with polysorbate 80. 2. Patients contraindicated to docetaxel, cisplatin, S-1, or G-CSF. 3. Documented or suspected infection. 4. Uncontrolled medical conditions (e.g., malignant hypertension, congestive heart failure, myocardial infarction in previous 3 months, arrhythmia requiring treatment, diabetes, interstitial pneumonia, pulmonary fibrosis). 5. Grade 2 or greater peripheral neuropathy. 6. Patients with brain metastasis 7. Patients with diarrhea. 8. Active concomitant malignancy. 9. Pregnant or lactating women and women of child bearing potential not using contraception. 10. Men with partner willing to get pregnant 11. Patients judged by the investigator as unfit to be enrolled in the study. 12. Patients already enrolled in this study.

Design outcomes

Primary

Measure	Time frame
Complete resection rate	—

Secondary

Measure	Time frame
Response rate Pathological response PFS, MST, 1-year survival, 3-year survival Toxicity	—

Countries

Japan

Contacts

Public ContactTetsuji Takayama, Yasushi Sato

Sapporo Medical University Dept. of Internal Medicine(4)

011-611-2111

Outcome results

None listed

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