UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000104 |
|---|---|
| Receipt number | 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 12:49:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
info@hictdo.or.jp
Sponsor or person
Institute
Hiroshima Cancer Therapy Development Organization (HiCTDO)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000153
