UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001777 |
|---|---|
| Receipt number | 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 00:32:09 |
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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 ≥ 3,500/µL
b) PLT ≥ 100,000/µL
c) Hb ≥ 9.0 g/dL
d) AST, ALT ≤ ULN x 2.0
e) T-Bil ≤ ULN x 2.0
f) CRE ≤ ULN or CCR ≥ 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
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
kinouchi@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Biological Regulation and Oncology, Department of Surgery, Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002139
