UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004780 |
|---|---|
| Receipt number | R000005683 |
| Scientific Title | Randamized phase II trial of S-1+CDDP vs S-1+Docetaxel for advanced and/or recurrent gastric cancer |
| Date of disclosure of the study information | 2011/01/15 |
| Last modified on | 2015/06/22 09:43:14 |
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Basic information
Public title
Randamized phase II trial of S-1+CDDP vs S-1+Docetaxel for advanced and/or recurrent gastric cancer
Acronym
CS vs DS for GC
Scientific Title
Randamized phase II trial of S-1+CDDP vs S-1+Docetaxel for advanced and/or recurrent gastric cancer
Scientific Title:Acronym
CS vs DS for GC
Region
| Japan |
Condition
Condition
advanced and/or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Non-recessive study compared the efficacy and the safety between the S-1+CDDP and S-1 + Docetaxel
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Time to progression
Key secondary outcomes
Median survival time
Response rate
The rate of adverse event
Median rate of continuing therapy
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
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: 1 cycle is consited of 5 weeks used S-1+CDDP
Interventions/Control_2
Group B: 1 cycle is consisted of 3 weeks used S-1 + Docetaxel
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Histologically proven adenocarcinoma of advanced gastric cancer(included esophagogastric junction)
2.Oral intake is possible
3.Presence of clear lesion for mesure
4.Performance status 0 to 1(ECOG)
5.Hemoglobin less than 8 g/dl, WBC counts is between 12000 and 4000
6.s-Creatinin level within normal limit
7.s-Bilirubin level within 1.5 X normal limit
8.S-GOT/GPT within 2.5Xnormal limit
9.Alkaline phosphatase within 2.5Xnormal limit
10.Without surgical influence
11.Witjout previous chemotherapy
12.Life expectancy is less than 3 months
13.Written informed conscent
Key exclusion criteria
1.With active other cancer(excluded early colonic cancer)
2.With active bleeding
3.With ascites needed to exclude
4.metastasis to the brain
5.With peripheral neuropathy more than
Grade 2
6.Interstitial pneumonia
7.With erethism history for 5-FU, TXT, polisorbate 80
8.Previouslly treated by chemoradiation
9.pregnancy and the person of intention to become pregnant
10. participated in other trial wiyhin 4 weeks
11.forbidden to use steroid
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirai Toshihiro |
Organization
Kawasaki Medical University
Division name
Department of Digestive Surgery
Zip code
Address
81-86-462-1111
TEL
086-462-1111
hiro0928@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Matsumoto |
Organization
Kawasaki Medical University
Division name
Department of Digestive surgery
Zip code
Address
577 Matsushima Kurashiki Okayama
TEL
086-462-1111
Homepage URL
h-matsu@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Digestive Surgery, Kawasaki Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Digestive Surgery, Kawasaki Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
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
Terminated
Date of protocol fixation
| 2011 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 22 | Day |
Last modified on
| 2015 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005683
