Chemotherapy-naï
Conditions
Interventions
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
Sponsors
Hiroshima Cancer Therapy Development Organization (HiCTDO)
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
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)With pathologically proven gastric cancer (2)With at least one measurable lesion (RECIST) (3)No prior irradiation and chemotherapy or 1 adjuvant chemotherapy regimen that was completed >=28 days prior to entry (4)ECOG performance status=12 weeks (7)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as: white blood cell count>=4000 mm3=2000 mm3, hemoglobin>=9.0 g/dl, platelet>=100,000 mm3, AST and ALT within two times the upper limit of normal for the institution, serum bilirubin level=60 ml/min. (8)With written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMasahiko Nishiyama
Research Institute for Radiation Biology and Medicine, Hiroshima University Department of Translational Cancer Research
Outcome results
None listed