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

UMIN ID: UMIN000000801

Registered date:15/08/2007

Basic Information

• Health condition(s) or Problem(s) studied: advanced gastric cancer
• Date of first enrollment: 2007/01/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

• Primary Outcome: Complete resection rate
• Secondary Outcome: Response rate Pathological response PFS, MST, 1-year survival, 3-year survival Toxicity

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Dept. of Internal Medicine(4)
• Source(s) of Monetary Support: None