UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001584 |
|---|---|
| Receipt number | 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 11:14:50 |
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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
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
hokabe@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Surgery
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001903
