UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054127 |
|---|---|
| Receipt number | R000061807 |
| Scientific Title | A multicenter observational study to evaluate the efficacy and safety of peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATATE in patients with unresectable neuroendocrine tumors (NEN). |
| Date of disclosure of the study information | 2024/04/12 |
| Last modified on | 2025/02/26 18:42:13 |
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Basic information
Public title
A multicenter observational study to evaluate the efficacy and safety of peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATATE in patients with unresectable neuroendocrine tumors (NEN).
Acronym
A multicenter observational study to evaluate the efficacy and safety of peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATATE in patients with unresectable neuroendocrine tumors (NEN).
Scientific Title
A multicenter observational study to evaluate the efficacy and safety of peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATATE in patients with unresectable neuroendocrine tumors (NEN).
Scientific Title:Acronym
A multicenter observational study to evaluate the efficacy and safety of peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATATE in patients with unresectable neuroendocrine tumors (NEN).
Region
| Japan |
Condition
Condition
Unresectable neuroendocrine tumors (NEN)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the present status of PRRT with 177Lu-DOTATATE for patients with NEN in Japan and assess its efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Progression-free survival, overall survival, disease control rate, adverse event rate, response rate by primary site, disease control rate by primary site, improvement rate of endocrine symptoms in functional tumors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients will include those who meet all of the following criteria and have received treatment at each institution between October 1, 2021, and December 31, 2023:
Histologically diagnosed NEN based on resection or biopsy specimen.
Unresectable or recurrent NEN.
Initiation of PRRT with 177Lu-DOTATATE.
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National cancer center hospital
Division name
Hepatobiliary and pancreatic oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo, Tokyo, Japan
TEL
81-3-3542-2511
shijioka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Okamoto |
Organization
National cancer center hospital
Division name
Hepatobiliary and pancreatic oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo, Tokyo, Japan
TEL
81-3-3542-2511
Homepage URL
kookamot@ncc.go.jp
Sponsor or person
Institute
National cancer center
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
National cancer center
Address
5-1-1 Tsukiji, Chuo, Tokyo, Japan
Tel
81-3-3542-2511
irst@ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JON2203-N
Org. issuing International ID_1
Japan Oncology Network in Hepatobiliary and Pancreas
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 | 04 | 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
| 2023 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter, retrospective study aimed at understanding the current status of PRRT for patients with unresectable NEN in Japan and evaluating its efficacy and safety.
Eligible patients will be those treated at each institution between October 1, 2021, and December 31, 2023, meeting all the following criteria:
1. Histologically diagnosed NEN based on resection or biopsy specimen.
2. Unresectable or recurrent NEN.
3. Initiation of PRRT with 177Lu-DOTATATE.
The data on study subjects will be collected from medical records and pathology databases at each institution.
Management information
Registered date
| 2024 | Year | 04 | Month | 12 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061807
