UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052522 |
|---|---|
| Receipt number | R000059908 |
| Scientific Title | A multicenter observational study of trastuzumab deruxtecan in elderly patients with previously treated HER2-positive advanced gastric cancer |
| Date of disclosure of the study information | 2023/10/31 |
| Last modified on | 2025/06/13 23:25:06 |
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Basic information
Public title
A multicenter observational study of trastuzumab deruxtecan in elderly patients with previously treated HER2-positive advanced gastric cancer
Acronym
EN-COURAGE study
Scientific Title
A multicenter observational study of trastuzumab deruxtecan in elderly patients with previously treated HER2-positive advanced gastric cancer
Scientific Title:Acronym
EN-COURAGE study
Region
| Japan |
Condition
Condition
HER2-positive gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
･To evaluate the effectiveness and safety of trastuzumab deruxtecan (T-DXd) in elderly patients with previously treated HER2-positive advanced gastric cancer.
･To evaluate the effectiveness and safety of T-DXd in elderly patients by geriatric 8 (G8) and other functional evaluations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival(OS)
Key secondary outcomes
･ Progression free survival (PFS)
･ Time to treatment failure (TTF)
･ Objective response rate (ORR)
･ Disease control rate (DCR)
･ Duration of response (DoR)
･ Time to treatment discontinuation (TTD)
･ Adverse events
･ Relationship between geriatric assessment (G8 score and other functional evaluations) and effectiveness / safety
･ T-DXd time to dose reduction
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
1. Aged 70 years or older at the time of informed consent
2. Unresectable advanced or recurrent gastric cancer (gastric or gastro-esophageal junction adenocarcinoma) that progressed after cancer chemotherapy
3. Histopathologically diagnosed HER2-positive (IHC 3+ or IHC2+ with ISH-positive) gastric cancer
*If the patient was diagnosed as HER2positive, the result of the HER2 test if the patient had undergone another HER2 test.
4. Had progressed after the patient had received at least 2 previous regimens, which included trastuzumab
5. Scheduled to receive T-DXd
6. ECOG PS 0-2
7. Written informed consent
Key exclusion criteria
1. Has a history of severe hypersensitivity reactions to either T-DXd substances or inactive ingredients in T-DXd
2. Patients with a prior treatment of T-DXd
3. Patients with a history of or concomitant interstitial lung disease, who are considered ineligible for treatment with T-DXd by the investigators
4. Patients who have active multiple primary malignancies which investigator determines to affect the evaluation of T-DXd
5. Patients judged by the investigator to be ineligible for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Muro |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku Nagoya 464-8681, Japan
TEL
052-762-6111
kmuro@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ota |
Organization
EPS Corporation
Division name
Clinical Research Center Real World Evidence Business Headquarters
Zip code
162-0814
Address
Acropolis TOKYO Bldg., 6-29 Shinogawamachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5804-5045
Homepage URL
prj-en-courage@eps.co.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center Ethical Review Board
Address
1-1 Kanokoden, Chikusa-ku Nagoya 464-8681, Japan
Tel
052-762-6111
irb-jimu@aichi-cc.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
愛知県がんセンター（愛知県）、岐阜大学医学部附属病院（岐阜県）、近畿大学病院（大阪府）、堺市立総合医療センター（大阪府）、富山大学附属病院（富山県）、鹿児島大学病院（鹿児島県）他 54施設
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059908
