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

Phase 2

• Conditions: Chemotherapy-naï ve metastatic gastric cancer

• Registration Number: JPRN-C000000104
• Lead Sponsor: Hiroshima Cancer Therapy Development Organization (HiCTDO)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-01
• Study Completion: 2011-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor response rate

Secondary Outcome Measures

Name	Time	Method
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