UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049032 |
|---|---|
| Receipt number | R000055365 |
| Scientific Title | Retrospective cohort study to evaluate the efficacy and safety of trastuzumab deruxtecan in patients with HER2-positive unresectable advanced or recurrent gastric cancer |
| Date of disclosure of the study information | 2022/10/12 |
| Last modified on | 2024/03/28 11:47:12 |
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Basic information
Public title
Retrospective cohort study to evaluate the efficacy and safety of trastuzumab deruxtecan in patients with HER2-positive unresectable advanced or recurrent gastric cancer
Acronym
EN-DEAVOR study
Scientific Title
Retrospective cohort study to evaluate the efficacy and safety of trastuzumab deruxtecan in patients with HER2-positive unresectable advanced or recurrent gastric cancer
Scientific Title:Acronym
EN-DEAVOR study
Region
| Japan |
Condition
Condition
HER2-positive unresectable advanced or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To collect real-world data and evaluate the effectiveness and safety of trastuzumab deruxtecan (T-DXd) in a population of HER2-positive unresectable advanced or recurrent gastric cancer (Gastric or Gastro-Esophageal Junction Adenocarcinoma) patients, in real world setting, who are not available from clinical studies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
[Efficacy]
1)Overall survival (OS)
2)Time to treatment failure (TTF)
3)Real world progression free survival (rwPFS)
4)Objective response rate (ORR)
5)Disease control rate (DCR)
6)Ascites response rate
7)Ascites control rate
8)Best percent change in the sum of the diameters for all target lesions
9)Duration of response (DoR)
10)Time to best response
11)Time to response
[Safety]
1)Incidence rate of adverse events of Grade 3 or higher under T-DXd treatment
2)Incidence rate of adverse events that led to dose reduction, postponement, or discontinuation of T-DXd administration under T-DXd treatment
3)Time to incidence of adverse events of Grade 3 or higher under T-DXd treatment
4)Time to the first dose reduction of T-DXd
5)Rate of treatment-related deaths
Key secondary outcomes
1)Relative dose intensity (RDI) and Time to dose adjustment
2)Rate of transition to surgery after T-DXd treatment
3)OS by best overall response rate
4)Trastuzumab free interval
5)Antiemetic prophylaxis status
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged 20 years or older when T-DXd administration is started
2)Histopathologicallydiagnosed HER2 positive (IHC3+ or IHC2+ with ISH+) gastric cancer (Gastric or Gastro-Esophageal Junction Adenocarcinoma)
3)Unresectable advanced or recurrent gastric cancer (Gastric or Gastro-Esophageal Junction Adenocarcinoma)
4) Have been started on T-DXd from 25 Sep 2020 to 30 Sep 2021
Key exclusion criteria
1)Patients who refuse to participate the study
2)Patients who have active multiple primary malignancies which investigator determines to affect the evaluation of T-DXd
3)Patients who have been administrated T-DXd on interventional clinical studies including clinical trials/expanded access program or at other medical institutions
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kodera |
Organization
Nagoya University Hospital･Nagoya University Graduate School of Medicine
Division name
Gastrointestinal surgery
Zip code
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi, Japan
TEL
052-741-2111
ykodera@med.nagoya-u.ac.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-deavor@eps.co.jp
Sponsor or person
Institute
Nagoya University Hospital･Nagoya University Graduate School of Medicine,Gastrointestinal surgery
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi, Japan
Tel
052-741-2111
iga-shinsa@adm.nagoya-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
名古屋大学医学部附属病院（愛知県）、愛知県がんセンター（愛知県）、他58施設
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 12 | 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
| 2022 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 20 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 18 | Day |
Other
Other related information
-
Management information
Registered date
| 2022 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055365
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