UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053395 |
|---|---|
| Receipt number | R000060933 |
| Scientific Title | ENSURE-GA2 study |
| Date of disclosure of the study information | 2024/01/19 |
| Last modified on | 2024/01/19 15:27:23 |
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Basic information
Public title
Prospective observational study assessing the relationship between adverse events in chemotherapy for older lung cancer patients.
Acronym
Prospective observational study assessing the relationship between adverse events in chemotherapy for older lung cancer patients.
Scientific Title
ENSURE-GA2 study
Scientific Title:Acronym
ENSURE-GA2 study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will examine whether CTCAE v5.0 is appropriate as a method to evaluate adverse events in drug therapy for elderly non-small cell lung cancer (NSCLC) patients, especially inhibition of ADL/IADL, and evaluate the risk of adverse events created from the results of the ENSURE-GA study. Consider the validity of the score.
Basic objectives2
Others
Basic objectives -Others
Relationship between the results of risk assessment conducted before drug therapy and the actual occurrence of adverse events (examined for each cytotoxic anticancer drug, molecular target drug, and immune checkpoint inhibitor)
Treatment completion rate
ECOG PS improvement rate of 1 level or more
Comparison of the proportion of patients who experienced CTCAE v5.0 grade 2 or higher adverse events (non-hematologic toxicity) and the proportion of patients whose Geriatric 8 score decreased by 1 or more points before and after treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the proportion of patients who experienced CTCAE v5.0 grade 2 or higher adverse events (non-hematologic toxicity) and the proportion of patients whose IADL decreased by one or more items before and after treatment
Key secondary outcomes
Relationship between the results of risk assessment conducted before drug therapy and the actual occurrence of adverse events (examined for each cytotoxic anticancer drug, molecular target drug, and immune checkpoint inhibitor)
Treatment completion rate
ECOG PS improvement rate of 1 level or more
Comparison of the proportion of patients who experienced CTCAE v5.0 grade 2 or higher adverse events and the proportion of patients whose Geriatric 8 score decreased by 1 or more points before and after treatment
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients with untreated stage IV or post-operative recurrence who was histologically or cytologically confirned as non-small-cell lung cancer
(2)ECOG performance status (PS) : 0-3
(3)Written informed concent
Key exclusion criteria
(1)Patients with dimentia
(2)Patients with psychiatric disorder
(3)Any other patients who are regarded as unsuitable for this study by the investigators
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Tsubata |
Organization
Department of Internal Medicine, Shimane University Faculty of Medicine
Division name
Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
+81-853-20-2580
ytsubata@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Tsubata |
Organization
Department of Internal Medicine, Shimane University Faculty of Medicine
Division name
Division of Medical Oncology & Respiratory Medicine
Zip code
693-8501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
+81-853-20-2580
Homepage URL
ytsubata@med.shimane-u.ac.jp
Sponsor or person
Institute
CS-Lung
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research support center, Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane
Tel
+81-853-20-2259
kenkyu@med.shimane-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
| 2024 | Year | 01 | Month | 19 | 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
| 2023 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Registration period April 2024 to March 2026
Management information
Registered date
| 2024 | Year | 01 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060933
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| Registered date | File name |
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