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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000104
Receipt No. R000000153
Scientific Title A randomized phase II (/III) study of TXT/TS-1 (DS) combination vs CDDP/5-FU therapy (FUP) in metastatic gastric cancer
Date of disclosure of the study information 2005/10/01
Last modified on 2011/09/18

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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
Registered date File name

Research case data
Registered date File name


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