UMIN-CTR Clinical Trial

Basic information
Public title	A randomized phase II (/III) study of TXT/TS-1 (DS) combination vs CDDP/5-FU therapy (FUP) in metastatic gastric cancer
Acronym	A randomized phase II study of TXT/TS-1 (DS) vs CDDP/5-FU (FUP) in metastatic gastric cancer
Scientific Title	A randomized phase II (/III) study of TXT/TS-1 (DS) combination vs CDDP/5-FU therapy (FUP) in metastatic gastric cancer
Scientific Title:Acronym	A randomized phase II study of TXT/TS-1 (DS) vs CDDP/5-FU (FUP) in metastatic gastric cancer
Region	Japan

Condition
Condition	Chemotherapy-naïve metastatic gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To compare docetaxel plus S-1 combination (DS) with CDDP/5-FU (FUP) for chemotherapy-naïve patients with advanced or recurrent gastric cancer
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	Tumor response rate
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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
Interventions/Control_2	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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key 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<=2 (5)Age 20-75 years (6)Life expectancy estimated>=12 weeks (7)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as: white blood cell count>=4000 mm3<=12,000 mm3, neutrophil count>=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<=1.5 mg/dl, BUN<=25 mg/dl, serum creatinine level<=1.5 mg/dl, creatinine clearance>=60 ml/min. (8)With written informed consent
Key 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
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiko Nishiyama
Organization	Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name	Department of Translational Cancer Research
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL	082-257-5839
Email

Public contact
Name of contact person	1st name Middle name Last name Masahiko Nishiyama
Organization	Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name	Department of Translational Cancer Research
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL	082-257-5839
Homepage URL	http://www.hictdo.or.jp/tiken.html
Email	info@hictdo.or.jp

Sponsor
Institute	Hiroshima Cancer Therapy Development Organization (HiCTDO)
Institute
Department

Funding Source
Organization	Hiroshima Cancer Therapy Development Organization (HiCTDO)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-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
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	HiCTDO protocol #4
Org. issuing International ID_1	Hiroshima Cancer Therapy Development Organization (HiCTDO)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2005 Year 10 Month 01 Day

Related information
URL releasing protocol	http://www.hictdo.or.jp/tiken.html
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date	2005 Year 05 Month 01 Day
Last follow-up date	2011 Year 06 Month 01 Day
Date of closure to data entry	2011 Year 06 Month 01 Day
Date trial data considered complete	2011 Year 06 Month 01 Day
Date analysis concluded	2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 09 Month 01 Day
Last modified on	2011 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000153

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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