UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004466 |
|---|---|
| Receipt number | 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 10:31:59 |
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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
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
hideaki.shimada@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005324
