UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055133 |
|---|---|
| Receipt number | R000062936 |
| Scientific Title | Prospective and and retrospective multicenter observational study of HER2 status just before T-DXd administration and treatment efficacy in patients with advanced gastric cancer. |
| Date of disclosure of the study information | 2024/08/02 |
| Last modified on | 2024/08/01 12:17:56 |
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Basic information
Public title
Prospective and and retrospective multicenter observational study of HER2 status just before T-DXd administration and treatment efficacy in patients with advanced gastric cancer.
Acronym
Prospective and and retrospective multicenter observational study of HER2 status just before T-DXd administration and treatment efficacy in patients with advanced gastric cancer.
Scientific Title
Prospective and and retrospective multicenter observational study of HER2 status just before T-DXd administration and treatment efficacy in patients with advanced gastric cancer.
Scientific Title:Acronym
HGCSG 2303
Region
| Japan |
Condition
Condition
Unresectable or advanced recurrent HER2-positive gastric cancer or cardioesophageal cancer.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the association between HER2 status and treatment outcome just before T-DXd administration to patients with advanced gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression free survival, Disease control rate, Overall survival, Safety, HER2 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. Patients who have failed prior trastuzumab-based chemotherapy for unresectable advanced or recurrent gastric cancer.
2. Patients who have undergone (or will undergo) tissue collection (biopsy or surgery) and HER2 testing after completion of trastuzumab-containing chemotherapy.
3. Over 20 years of age.
4. Eastern Cooperative Oncology Group(ECOG) Performance Status(PS) 0-2.
5. Written informed consent.
Key exclusion criteria
1. Those with active multiple cancers.
2. Those who had drainage for fluid retention (pleural, ascites, pericardial fluid, etc.) within 2 weeks prior to enrollment.
3. Patients with pulmonary fibrosis or interstitial pneumonia.
4. Those with serious complications.
5. Those with active infectious diseases.
6. Those with active viral hepatitis.
7. Poorly controlled diabetes mellitus patients.
8. Those with serious psychiatric or central nervous system disorders.
9. Those with severely abnormal electrocardiogram or with clinically problematic cardiac condition.
10. Other individuals who are judged by the research director or co-researcher to be inappropriate as research subjects.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Komatsu |
Organization
Hokkaido University Hospital
Division name
Division of Cancer Center
Zip code
060-8648
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido, Japan
TEL
0117161161
ykomatsu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Ishida |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido, Japan
TEL
0117161161
Homepage URL
ishida.koichi.e3@elms.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university hospital, Hokkaido Gastrointestinal Cancer Study Group(HGCSG)
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
0117161161
crjimu@huhp.hokudai.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 | 08 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research implementation period: Until March 31, 2026
Management information
Registered date
| 2024 | Year | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062936
