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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004466
Receipt No. R000005324
Scientific Title A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.
Date of disclosure of the study information 2010/10/28
Last modified on 2017/05/01

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Basic information
Public title A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.
Acronym A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.
Scientific Title A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.
Scientific Title:Acronym A phase II trial of TS-1/CDDP as neoadjuvant chemotherapy against resectable gastric cancer.
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim is to evaluate the clinical pathology effects of TS-1 plus cisplatin as a neoadjuvant chemotherapy against resectable gastric cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect of the tumor reduction of providing by the chemotherapy effect judgment standard is used.
The doctor in charge judges the effect of the tumor reduction based on RECIST(http://www.recist.com/recist-in-practice/22.html) version 1.1.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TS-1: Day1-21, p.o. and CDDP: Day8.
1 course takes 35 days.
1 course
Interventions/Control_2 TS-1: Day1-21, p.o. and CDDP: Day8.
1 course takes 35 days.
2 courses
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.Primary gastric adenocarcinoma
2.The pathological material of the gastric carcinoma before chemotherapy
3.M (-),H (-),c-StageIII and IV in the staging classification
4.Adjustment of Neoadjuvant chemotherapy with TS-1+CDDP
5.Measurable lesions according to RECIST guidelines
6.No history of pretreatment (radiotherapy, chemotherapy,etc.) except surgery
7.PS(ECOG) is 0-2
8.Adequate organ function
WBC>=4000/mm3
Neutrophil count>=2,000/mm3
Platelet count>=100,000/mm3
Hemoglobin>=8.0 g/dL
9.Liver function tests
AST (GOT) and ALT (GPT) <=100IU/L
Total bilirubin<=2.0 mg/dL
10.Renal function test
CCr(e-GFR)>=60ml/min
Serum creatinine<=1.50 mg/dL
11.Age 20 to 80 years old
12.With written informed consent
Key exclusion criteria 1.Metachronous or synchronous multiple cancer
2.Pregnant or in lactation.
3.Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Shimada
Organization Toho University School of Medicine
Division name Division of general and Gastroenterological Surgery,Department of Surgery(Omori)
Zip code
Address 6-11-1 Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan
TEL 03-3762-4151
Email hideaki.shimada@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideaki Shimada
Organization Toho University School of Medicine
Division name Division of general and Gastroenterological Surgery,Department of Surgery(Omori)
Zip code
Address 6-11-1 Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan
TEL 03-3762-4151
Homepage URL
Email hideaki.shimada@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 10 Month 28 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 Completed
Date of protocol fixation
2010 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 27 Day
Last modified on
2017 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005324

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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