Phase I/II study of the combination of docetaxel, CDDP and S-1 in patients with unresectable advanced gastric cancer

UMIN ID: C000000080

Registered date:01/09/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: unresectable advanced gastric cancer
• Date of first enrollment: 2005/03/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Treatment consisting of TS-1 (80mg/m2, day 1 - 14),CDDP (60 mg/m2, day 8) and Docetaxel (60mg/m2, day 8). This treatment was repeated more than 3 times every 3 wks.

Outcome(s)

• Primary Outcome: efficacy
• Secondary Outcome: survival(PFS,MST) toxicity

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria included: active infection; serious complications (severe heart disease, pulmonary fibrosis, interstitial pneumonitis and tendency to bleeding); neuropathy grade 2; edema grade 2 (NCI-CTC); active concomitant malignancy; symptomatic metastases of the central nervous system; history of drug hypersensitivity (including TXT,CDDP,TS-1 or G-CSF); serious diarrhea; pregnant and lactating females; females of childbearing age, unless using effective contraception; and other serious medical conditions.

Related Information

• Primary Sponsor: Fourth Department of Internal Medicine, Sapporo Medical University
• Source(s) of Monetary Support: Fourth Department of Internal Medicine, Sapporo Medical University