UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048629 |
|---|---|
| Receipt number | R000055410 |
| Scientific Title | Multicenter prospective observational study for the usefulness of geriatric assessment before chemotherapy in elderly patients with gastric cancer |
| Date of disclosure of the study information | 2022/08/09 |
| Last modified on | 2022/08/09 01:21:54 |
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Basic information
Public title
Multicenter prospective observational study for the usefulness of geriatric assessment before chemotherapy in elderly patients with gastric cancer
Acronym
GA study
Scientific Title
Multicenter prospective observational study for the usefulness of geriatric assessment before chemotherapy in elderly patients with gastric cancer
Scientific Title:Acronym
GA study
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the relationship between geriatric assessment before chemotherapy and adverse event rates or treatment results in elderly patients with gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event rates of grade 3-4 during first-line chemotherapy
Key secondary outcomes
RDI(Relative dose intensity) during first-line chemotherapy, overall survival (OS), progression free survival (PFS), overall response rate (ORR), time to treatment failure (TTF), and the relationship between GA scores and adverse events or treatment results
Base
Study type
Observational
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
| 70 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
ECOG PS 0-2
Patients who are going to receive platinum combination chemotherapy
Patients who have written informed consent
Patients over 70 years old
Key exclusion criteria
Recurrent cases during preoperative or postoperative chemotherapy
Cases of clinical trial
Patients who can not understand disease condition due to severe cognitive impairment
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyasu |
| Middle name | |
| Last name | Kono |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama City
TEL
086-235-7219
hxnwq178@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshiyasu |
| Middle name | |
| Last name | Kono |
Organization
Okayama University Hospital
Division name
Gastroenterology
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama City
TEL
086-235-7219
Homepage URL
hxnwq178@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Okayama University Hospital, Ethics Comittee
Address
2-5-1, Shikata-cho, Kita-ku, Okayama City
Tel
086-235-6938
mae6605@adm.okayama-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
| 2022 | Year | 08 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 08 | Month | 09 | Day |
Last modified on
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055410
