Phase II study of a combination of TS-1 and TXL for advanced/recurrent gastric cancer patients with peritoneal metastasis

UMIN ID: UMIN000000746

Registered date:29/06/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with gastric cancer and peritoneal metastasis
• Date of first enrollment: 2004/03/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): TXL 50mg/m2 is administered on day 1 and day 8. And TS-1 80 mg/m2 is administered from day 1 to day 14 (14 days). One course is these 14days and subsequent no-treatment 7 days.

Outcome(s)

• Primary Outcome: Overall Survival
• Secondary Outcome: Response Rate Time To No oral intake Time To Progression Adverse Events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1.with severe cavity fluid which needs drainage 2.with a central nerve symptoms 3.with fresh intestinal beeding 4.with active double cancers 5.with an allergic reaction against TS-1 or TXL 6.with severe allergy against medicine 7.with severe diseases (cardiac failure, arrhythmia, renal dysfunction, liver dysfunction, interstitial pneumonia, severe neural disorder, uncontrolled DM, intestinal obstruction, etc.) 8.under pregnancy or nursing 9.doctors' decision not to register

Related Information

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