A randomized phase II (/III) study of TXT/TS-1 (DS) combination vs CDDP/5-FU therapy (FUP) in metastatic gastric cancer

UMIN ID: C000000104

Registered date:01/10/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chemotherapy-naïve metastatic gastric cancer
• Date of first enrollment: 2005/05/01
• Target sample size: 130
• 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
Intravenous continuous administration of 5-FU 800 mg/m2/day on Day 1 to Days 5 and intravenous administration of 80 mg/m2/day CDDP on Day 2 every 4 weeks

Outcome(s)

• Primary Outcome: Tumor response rate
• Secondary Outcome: 1)Duration of a CR, PR, or SD 2)Progression free-survival (PFS) and time to treatment failure (TTF) 3)Median overall survival (MST), 1- and 2-year survival rate, 4)Adverse events 5)Possible Biomarker a)Association of genotype, mutation, and expression of ABCB1, CYP3A4, GSTP1, POR, TUBB, DPYD, and TYMS with phenotype b)Development of efficacy prediction model using ABCB1, ABCG2, CYP2C8, CYP3A4, DPYD, GSTP1, MGMT, NQO1, POR, TOP2A, TUBB, and TYMS c)Identification of possible biomarker genes other than ABCB1, CYP3A4, GSTP1, POR, TUBB, DPYD, and TYMS

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: (1)Accompanied serious diseases (2)Prior adjuvant chemotherapy including a taxane, TS-1, CDDP and 5-FU (3)Oral uptake disturbance (4)A past history of drug allergy (5)A past history of allergic reaction to polysorbate 80 (6)Symptomatic pleural effusion or ascites (7)Symptomatic infectious disease (8)Watery diarrhea (9)Ileus and obstructive bowel disease (10)Pulmonary fibrosis, interstitial pneumonia, symptomatic bleeding tendency, and Hemorrhage/bleeding>=grade 3 (NCI- CTC) (11)Peripheral neuropathy>=grade 2 (12)Edema>=grade 2 (13)Concomitant therapy with flucytocine (14)Active secondary cancer (15)Uncontrollable diabetes (16)Congestive heart failure, symptomatic ischemic heart disease, poorly controlled arrhythmia, A-V block>=grade 2, myocardial infarction cooured within 12 months (17)Symptomatic psychological disease (18)Pregnancy or breast feeding (19)Decision as ineligible by principal investigator

Related Information

• Primary Sponsor: Hiroshima Cancer Therapy Development Organization (HiCTDO)
• Secondary Sponsor: Hokkaido Univ, Asahikwa-Kosei General Hosp,Hakodate Goryoukaku Hosp,Nishi Sapporo Natl Hosp, Sapporo Social Insurance General Hosp, Sakai City Hosp, Hiroshima Univ, Okayama Univ, Saitama Medcl College
• Source(s) of Monetary Support: Hiroshima Cancer Therapy Development Organization (HiCTDO),None
• Secondary ID(s): HiCTDO protocol #4