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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004780
Receipt No. 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

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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
Email 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
Email h-matsu@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Digestive Surgery, Kawasaki Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005683

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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