UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024465 |
|---|---|
| Receipt number | R000028160 |
| Scientific Title | Randomized phase II/III trial of steroid administration before gastric cancer surgery |
| Date of disclosure of the study information | 2016/10/18 |
| Last modified on | 2019/04/21 17:16:15 |
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Basic information
Public title
Randomized phase II/III trial of steroid administration before gastric cancer surgery
Acronym
Randomized phase II/III trial of steroid administration before gastric cancer surgery
Scientific Title
Randomized phase II/III trial of steroid administration before gastric cancer surgery
Scientific Title:Acronym
Randomized phase II/III trial of steroid administration before gastric cancer surgery
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of steroid administration before surgery for patients with cStage II/III gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
peak CRP value after surgery (phase II)
recurrence-free survival (phase III)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Administration of Methylprednisolone Sodium Succinate 5mg/kg
Interventions/Control_2
No administration
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 cancer
2) cStage II or III
3) Possible for R0 resection
4) Planned total, distal, or proximal gastrectomy
5) Aged 20 to 80 years old
6) PS(ECOG) of 0 or 1
7) Adequate organ functions defined as indicated below;
WBC: 3000-12000/mm3
Platelet: 75000/mm3-
AST: -100IU/L
ALT: -100IU/L
T-Bil: -2.0mg/dl
Cr: -1.5mg/dl
8) Written informed consent from patient
Key exclusion criteria
1) Emergency surgery
2) Uncontrollable diabetes mellitus or administration of insulin
3) Active infectious disease
4) Continuous steroid therapy
5) Past history of allergy for steroid
6) Past history of myocardial infarction or cerebral infarction
7) HBs antigen positive or HIV antibody positive
8) Enrolled in another interventional study which has severe impact on this study
9) Judged it inappropriate by physician
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Doki |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
5650871
Address
2-2, Yamadaoka, Suita 565-0871, Osaka
TEL
06-6879-3251
ydoki@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukinori |
| Middle name | |
| Last name | Kurokawa |
Organization
Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
5650871
Address
2-2, Yamadaoka, Suita 565-0871, Osaka
TEL
06-6879-3251
Homepage URL
ykurokawa@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Clinical Research Group for Gastroenterological Study
Institute
Department
Personal name
Funding Source
Organization
Nonprofit Organization of the Supporting Center for Clinical Research and Education
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Osaka University Hospital
Address
Institutional Review Board, Osaka University Hospital
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
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
| 2016 | Year | 10 | Month | 18 | 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
410
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
| 2016 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 18 | Day |
Last modified on
| 2019 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028160
