UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028411 |
|---|---|
| Receipt number | 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 | 2021/08/13 20:17:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tuburayaa@gmail.com
Sponsor or person
Institute
Tsuboi Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
