UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019519 |
|---|---|
| Receipt number | R000022575 |
| Scientific Title | A pooled data analysis of four randomized phase III trials (SPIRITS, GC0301/TOP-002, START, G-SOX) using individual patient data in advanced gastric cancer. |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2025/05/30 11:31:54 |
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Basic information
Public title
A pooled data analysis of four randomized phase III trials (SPIRITS, GC0301/TOP-002, START, G-SOX) using individual patient data in advanced gastric cancer.
Acronym
A pooled data analysis of advanced gastric cancer
Scientific Title
A pooled data analysis of four randomized phase III trials (SPIRITS, GC0301/TOP-002, START, G-SOX) using individual patient data in advanced gastric cancer.
Scientific Title:Acronym
A pooled data analysis of advanced gastric cancer
Region
| Japan | Asia(except Japan) |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyze prognostic and to investigate the prognosis factor by the data of four randomized controlled trials (SPIRITS, GC0301/TOP-002, START, G-SOX).
Clinical trials number
- SPIRITS: ClinicalTrials.gov number: NCT00150670
- GC0301/TOP-002: JapicCTI-050083
- START: ClinicalTrials.gov number: NCT00287768
- G-SOX: JapicCTI-101021
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) OS: Overall Survival
(2) PFS: Progression-Free Survival
(3) To evaluate the prognosis factor
(4) To evaluate the correlation between OS and PFS
(5) To evaluate the correlation between Tumor srinkage and OS, between Tumor srinkage and PFS
(6) To evaluate the correlation between Post Progression Free Survival and first line treatment
(7) To evaluate the correlation between Relative Dose Intensity and prognosis
Key secondary outcomes
In addition, other exploratory data analysis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cases who registered and analyzed in four randomized controlled study of advanced gastric cancer.
Key exclusion criteria
Any cases who registered other randomized studies or phase I or II studies.
Target sample size
1700
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Fujii |
Organization
Japan Clinical Cancer Reseach Organization (JACCRO)
Division name
Research Office
Zip code
101-0051
Address
6F Jimbocho Kyowa Bldg, 1-64-3 Kanda-Jimbocho, Chiyoda-ku, Tokyo
TEL
03-6811-0433
jaccro@jaccro.or.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Fujii |
Organization
Japan Clinical Cancer Reseach Organization (JACCRO)
Division name
Research Office
Zip code
101-0051
Address
6F Jimbocho Kyowa Bldg, 1-64-3 Kanda-Jimbocho, Chiyoda-ku, Tokyo
TEL
03-6811-0433
Homepage URL
jaccro@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Reseach Organization (JACCRO)
Institute
Department
Personal name
Funding Source
Organization
Japan Clinical Cancer Reseach Organization (JACCRO)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Clinical Cancer Reseach Organization (JACCRO)
Address
Research Office
Tel
03-6811-0433
jaccro@jaccro.or.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
| 2015 | Year | 10 | Month | 28 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze prognostic and to investigate the prognosis factor by the data of four randomized controlled trials (SPIRITS, GC0301/TOP-002, START, G-SOX).
Clinical trials number
- SPIRITS: ClinicalTrials.gov number: NCT00150670
- GC0301/TOP-002: JapicCTI-050083
- START: ClinicalTrials.gov number: NCT00287768
- G-SOX: JapicCTI-101021
(1) OS: Overall Survival
(2) PFS: Progression-Free Survival
(3) To evaluate the prognosis factor
(4) To evaluate the correlation between OS and PFS
(5) To evaluate the correlation between Tumor srinkage and OS, between Tumor srinkage and PFS
(6) To evaluate the correlation between Post Progression Free Survival and first line treatment
(7) To evaluate the correlation between Relative Dose Intensity and prognosis
(8) In addition, exploratory data analysis
Management information
Registered date
| 2015 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022575
