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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001584
Receipt No. R000001903
Scientific Title A Phase II study of neoadjuvant chemotherapy with S-1 and cisplatin for Stage III gastric cancer
Date of disclosure of the study information 2008/12/17
Last modified on 2015/06/17

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Basic information
Public title A Phase II study of neoadjuvant chemotherapy with S-1 and cisplatin for Stage III gastric cancer
Acronym A Phase II study of neoadjuvant chemotherapy with S-1 and cisplatin for Stage III gastric cancer (KUGC03)
Scientific Title A Phase II study of neoadjuvant chemotherapy with S-1 and cisplatin for Stage III gastric cancer
Scientific Title:Acronym A Phase II study of neoadjuvant chemotherapy with S-1 and cisplatin for Stage III gastric cancer (KUGC03)
Region
Japan

Condition
Condition Stage III 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+CDDP for resectable stage III gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 3 year progression free survival rate
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 chemotherapy+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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Pathologically confirmed gastric cancer
2)cT3/4 or cN2, not Stage IV
3)No previous treatment
4)Age between 20 and 80 years old
5)ECOG 0 or 1
6)Capable of oral administration
7)Informed concent
8)Biology and biochemistry within normal limits
Key exclusion criteria 1)Active bleeding from the tumor
2)Paralysis of intestine or ileus
3)Diarrhea(watery stool)
4)Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium
5)Synchronous multicancer
6)Serous infection
7)Interstitial pneumonitis or fibroid lung
8)Pleural effusion or ascites requiring control
9)Uncontrollable diabetes mellitus, uncontrollable hypertention, heart insufficiency, myocardial infarction within 6 months,uncontrolled arrhythmia or angina
10)Patient who is pregnant or in lactation, or wish to become pregnant during this study.Male patient who intends to make someone pregnant during this study
11)Patient who has experienced serious drug allergy in the past
12)Patient with severe phyciatric disease
13)Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge
Target sample size 49

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu SAKAI
Organization Graduate School of Medicine, Kyoto University
Division name Department of Surgery
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Kyoto University
Division name Department of Surgery
Zip code
Address
TEL 075-751-3227
Homepage URL
Email hokabe@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Surgery
Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Department of Surgery
Graduate School of Medicine, Kyoto 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
2008 Year 12 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://meetinglibrary.asco.org/content/125681-144
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 Main results already published
Date of protocol fixation
2008 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2012 Year 12 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
2008 Year 12 Month 17 Day
Last modified on
2015 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001903

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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