A Phase I/II study of combination of TS-1, CDDP plus PTX in patients with advanced/recurrent gastric cancer (OGSG 0703)

UMIN ID: UMIN000002183

Registered date:10/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced/recurrent gastric cancer
• Date of first enrollment: 2009/05/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Treatment Methd CDDP 30mg/m2:day 1, day15, PTX 70mg/m2:day 1, day15, TS-1 80/mgm2:day1 – 21(on), day22 – 35(off) A 5 weeks is the one course

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: overall survival(OS),progression free survival, and Incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: (1) with bleeding from digestive tract (2) patients who cannot take orally due to some stenosis on digestive tract (3) past history of severe allergy against some medicines (4) with high volume of ascites and/or thoratic fluid (5) with severe diseases (infection, interstitial pneumonitis, pulmonary fibrosis, cardiac failure, renal failure, liver disease, uncontrollable DM) (6) with liver cirrhosis and/or jaundice (7) with psychologic disorder which needs medicines (8) with brain disorder due to brain metastasis (9) with active second cancers. (10) women under pregnancy or women expecting future birth (11) doctors decision not to register to this trial

Related Information

• Primary Sponsor: OGSG
• Source(s) of Monetary Support: NPO Osaka Chinical Study Supporting Organization