Phase II study of modified S-1, docetaxel and cisplatin combination chemotherapy (mDCS) in patients with unresectable metastatic gastric cancer.

UMIN ID: UMIN000002361

Registered date:01/10/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 2010/05/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Treatment with docetaxel+Cisplatin+S-1 combination chemotherapy. Docetaxel 50mg/m2 iv (d8), Cisplatin 60mg/m2 iv (d8), S-1 80mg/m2 po (BID) (d1-14)

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Overall survival, progression free survival, time to response, duration of response, safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1)History of hypersensitivity to DCS. 2)Contraindication to TXT, CDDP, S-1, G-CSF. 3)Infectious disease. 4)Severe compliaction. 5)Neuropathy greater than grade 2. 6)Brain metastasis with clinical symptoms. 7)Watery diarea. 8)Active double cancer. 9)Persons to be pregnant or to make pregnant.

Related Information

• Primary Sponsor: Tokushima-Hokkaido cancer therapy clinical trial group
• Source(s) of Monetary Support: Self-funding