UMIN-CTR Clinical Trial

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
Last 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
Email	ydoki@gesurg.med.osaka-u.ac.jp

Public contact
1st 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
Email	ykurokawa@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Clinical Research Group for Gastroenterological Study
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028160