UMIN-CTR Clinical Trial

Basic information
Public title	Identification of clinical biomarkers for adjuvant chemotherapy for gastric cancer after D2 dissection by analyses of individual patients' data from large randomized controlled trials
Acronym	Clinical biomarker study for adjuvant chemotherapy for gastric cancer after D2 surgery in RCTs
Scientific Title	Identification of clinical biomarkers for adjuvant chemotherapy for gastric cancer after D2 dissection by analyses of individual patients' data from large randomized controlled trials
Scientific Title:Acronym	Clinical biomarker study for adjuvant chemotherapy for gastric cancer after D2 surgery in RCTs
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We are planning pooled analyses for ACTS-GC, CLASSIC, and SAMIT trials to identify prognostic factors for patients with gastric cancer curatively treated by D2 gastrectomy; and predictive factors in adjuvant chemotherapy and in each regimen for those patients. Postoperative survival prediction models will also be developed for patients treated by adjuvant chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	relapse-free survival
Key secondary outcomes	overall survival, toxicities and compliance

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	randomized patients
Key exclusion criteria	patients with no data
Target sample size	3521

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Tsuburaya
Organization	Tsuboi Cancer Center Hospital
Division name	Surgery
Zip code	963-0197
Address	1-10-13, Nagakubo, Asakamachi 9630197 Koriyama, Japan
TEL	080-24946-0808
Email	tuburayaa@gmail.com

Public contact
Name of contact person	1st name Akira Middle name Last name Tsuburaya
Organization	Tsuboi Cancer Center Hospital
Division name	Surgery
Zip code	963-0197
Address	1-10-13, Nagakubo, Asakamachi 9630197 Koriyama, Japan
TEL	080-24946-0808
Homepage URL
Email	tuburayaa@gmail.com

Sponsor
Institute	Tsuboi Cancer Center Hospital
Institute
Department

Funding Source
Organization	Tsuboi Cancer Center Hospital
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	Tsuboi Cancer Center Hospital
Address	1-10-13, Nagakubo, Asakamachi 9630197 Koriyama, Japan
Tel	080-24946-0808
Email	tuburayaa@gmail.com

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	2017 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://doi.org/10.1007/s10120-021-01228-y
Number of participants that the trial has enrolled	3
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	2017 Year 05 Month 08 Day
Date of IRB	2017 Year 09 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2021 Year 08 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Relapse-free survival and overall survival according to treatment groups and trials will be described by Kaplan-Meier methods. Distributions of clinical and pathological factors will be described as well and will be compared across trials by ANOVA or the Fisher exact tests. For adjuvant groups, hazard ratios of capecitabine and oxaliplatin in CLASSIC vs. S-1 in ACTS-GC, and paclitaxel then S-1 in SAMIT vs. S-1 in ACTS-GC will be estimated by Cox regression adjusted for clinical and pathological factors. Predictive factors for adjuvant chemotherapy will be identified by examining the difference in relapse-free survival or overall survival between treatment groups, i.e. adjuvant plus surgery vs. surgery alone, in all combined patients of ACTS-GC, CLASSIC, and SAMIT. Relapse-free survival and overall survival according to treatment groups and subgroups (defined based on the clinical and pathological factors) will be described by Kaplan-Meier methods. The hazard ratios, 95% confidence intervals, and p values of the treatment groups will be estimated by stratified Cox regression using trial as the stratified factor. Tests for treatment-subgroup interactions will be examined by stratified Cox regression including a treatment-subgroup interaction as a covariate and trial as the stratified factor. The hazard ratios, 95% confidence intervals, p values and the baseline survival functions of the final models which include significant interactions will be estimated and a postoperative survival prediction model will be developed based on the estimates.

Management information
Registered date	2017 Year 07 Month 27 Day
Last modified on	2021 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032521