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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001777
Receipt No. R000002139
Scientific Title A Phase II trial of neoadjuvant chemotherapy with S-1 and fractional cisplatin for locally advanced gastric cancer
Date of disclosure of the study information 2009/03/16
Last modified on 2009/03/16

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Basic information
Public title A Phase II trial of neoadjuvant chemotherapy with S-1 and fractional cisplatin for locally advanced gastric cancer
Acronym A Phase II trial of neoadjuvant chemotherapy with S-1 and fractional cisplatin for locally advanced gastric cancer
Scientific Title A Phase II trial of neoadjuvant chemotherapy with S-1 and fractional cisplatin for locally advanced gastric cancer
Scientific Title:Acronym A Phase II trial of neoadjuvant chemotherapy with S-1 and fractional cisplatin for locally advanced gastric cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety and efficacy of neoadjuvant chemotherapy with S-1 plus fractional cisplatin for locally advanced gastric cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate, pathological response
Key secondary outcomes Over all survival , relapse free survival, curative resection rate, operative complication rate, adverse event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Chemotherapy and surgery
Interventions/Control_2
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 Selection Criteria
1)Pathologically confirmed gastric cancer
2) i)cStageIIIa or IIIb
ii)Borrmann Type III with the maximum tumor diameter of 8cm or more
iii)Borrmann Type IV
3) a case with clinically resectable legion
4) a case with target lesion or measurable lesion
5) No previous treatment
6) Age between 20 and 75 years old when an informed concent was taken.
7) ECOG 0 or 1 Informed concent
8)Biology and biochemistry data are fit for the following criteria within 14 days before registration.
a) WBC &#8805; 3,500/&micro;L
b) PLT &#8805; 100,000/&micro;L
c) Hb &#8805; 9.0 g/dL
d) AST, ALT &#8804; ULN x 2.0
e) T-Bil &#8804; ULN x 2.0
f) CRE &#8804; ULN or CCR &#8805; 50ml/min
9) Patient who can eat orally and is judged to be appropriate for neoadjuvant chemotherapy by the principal investigator
10) written informed consent to participate in the study.
Key exclusion criteria Exclusion criteria
1)Fresh bleeding from the tumor
2)Paralysis of intestine or ileus
3)Diarrhea(watery stool)
4) Synchronous multicancer
5) infection
6) Interstitial pneumonitis or fibroid lung
7) a large amount of pleural effusion or ascites
8) Jaundice
9)Uncontrollable diabetes mellitus, 10) heart failure requiring the treatment, myocardial infarction within 6 months, uncontrolled arrhythmia or angina
11)Patients pregnant or in lactation, or wish to become pregnant during this study. Male patients who intend to make someone pregnant during this study
12)Patient who has experienced serious drug allergy in the past
13)Patient who is judged to be inappropriate for this study by the principal investigator or the doctors in charge
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iwao Sasaki
Organization Tohoku University, Graduate School of Medicine
Division name Division of Biological Regulation and Oncology, Department of Surgery
Zip code
Address 1-1 Seiryo machi, Aoba-ku, Miyagi, Japan
TEL 022-717-7205
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Kinouchi
Organization Graduate School of Medicine, Tohoku University
Division name Division of Biological Regulation and Oncology, Department of Surgery
Zip code
Address 1-1 Seiryo machi, Aoba-ku, Miyagi, Japan
TEL 022-717-7205
Homepage URL
Email kinouchi@surg1.med.tohoku.ac.jp

Sponsor
Institute Division of Biological Regulation and Oncology, Department of Surgery, Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization Division of Biological Regulation and Oncology, Department of Surgery, Graduate School of Medicine, Tohoku University
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
2009 Year 03 Month 16 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
Date of protocol fixation
2007 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2013 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 16 Day
Last modified on
2009 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002139

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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