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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028411
Receipt No. R000032521
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
Date of disclosure of the study information 2017/07/30
Last modified on 2017/07/27

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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
Middle name
Last name Akira Tsuburaya
Organization Tsuboi Cancer Center Hospital
Division name Surgery
Zip code
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
Middle name
Last name Akira Tsuburaya
Organization Tsuboi Cancer Center Hospital
Division name Surgery
Zip code
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
Address
Tel
Email

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 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
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
2017 Year 07 Month 27 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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