Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer

UMIN ID: C000000103

Registered date:01/10/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Metastatic gastric cancer (Advanced or recurrent gastric cancer)
• Date of first enrollment: 2002/08/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Intravenous administration of 40 mg/m2 docetaxel on Day 1 and oral administration of 80 mg/m2/day S-1 on Days 1 to 14 every 3 weeks

Outcome(s)

• Primary Outcome: Tumor response rate
• Secondary Outcome: 1)Adverse events, 2)Progression free-survival (PFS) 3)Median overall survival (MST)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)Symptomatic infectious disease 2)Accompanied serious diseases such as pulmonary fibrosis, interstitial pneumonia, and symptomatic bleeding tendency 3)Peripheral neuropathy>=grade 2 4)Edema>=grade 2 5)Active secondary cancer 6)Symptomatic pleural effusion or ascites 7)Pregnancy or breast feeding 8)Obstructive bowel disease 9)Concomitant therapy with another anticancer drug or flucytocine 10)Past history of allergic reaction to polysorbate 80 11)A past history of drug allergy 12)A past history of allergic reaction to alcohol 13)Symptomatic psychological disease, or uncontrollable diabetes 14)Hemorrhage/bleeding>=grade 3 (NCI-CTC) 15)Decision as ineligible by principal investigator

Related Information

• Primary Sponsor: Hiroshima Cancer Therapy Development Organization (HiCTDO)
• Secondary Sponsor: Hiroshima Univ., Hokkaido Univ., Fukushima Med. Univ., Hiroshima City Hosp., Hiroshima City Asa Hosp.
• Source(s) of Monetary Support: Hiroshima Cancer Therapy Development Organization (HiCTDO),None
• Secondary ID(s): HiCTDO protocol #1