UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058068 |
|---|---|
| Receipt number | R000066370 |
| Scientific Title | A Multicenter Retrospective Observational Study on the Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) Retreatment (R-PRRT) Using 177Lu-DOTATATE for Neuroendocrine Neoplasms (NEN) |
| Date of disclosure of the study information | 2025/06/03 |
| Last modified on | 2025/06/03 16:24:07 |
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Basic information
Public title
A Multicenter Retrospective Observational Study on the Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) Retreatment (R-PRRT) Using 177Lu-DOTATATE for Neuroendocrine Neoplasms (NEN)
Acronym
R-PRRT retrospective study
Scientific Title
A Multicenter Retrospective Observational Study on the Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) Retreatment (R-PRRT) Using 177Lu-DOTATATE for Neuroendocrine Neoplasms (NEN)
Scientific Title:Acronym
R-PRRT retrospective study
Region
| Japan |
Condition
Condition
Neuroendocrine Neoplasms
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy and safety of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy for neuroendocrine neoplasms, using data obtained from medical records.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective Response Rate (ORR)
Key secondary outcomes
progression-free survival (PFS); disease control rate (DCR); objective response rate (ORR) by primary tumor site; disease control rate (DCR) by primary tumor site; the interval from the last administration of initial PRRT (I-PRRT) to the initiation of retreatment PRRT (R-PRRT); incidence of major hematologic toxicities; incidence of nephrotoxicity; and incidence of other adverse events.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who meet all of the following criteria will be included in the study:
1. Histologically confirmed diagnosis of neuroendocrine neoplasm (NEN).
2. Presence of unresectable and/or recurrent NEN.
3. Completion of four cycles of initial peptide receptor radionuclide therapy (I-PRRT) with 177Lu-DOTATATE.
4. Receipt of at least one cycle of retreatment PRRT (R-PRRT) with 177Lu-DOTATATE by March 31, 2025.
Key exclusion criteria
1. Those who have received either initial PRRT (I-PRRT) or retreatment PRRT (R-PRRT) abroad, even once.
2. Those whom the attending physician deems inappropriate for inclusion in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku Tokyo, Japan
TEL
+81-3-3542-2511
shijioka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Komori |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
+81-3-3542-2511
Homepage URL
yakomor@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
National Cancer Center Hospital
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
+81-3-3542-2511
yakomor@ncc.go.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
| 2025 | Year | 06 | Month | 03 | 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
30
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
| 2024 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who received at least one cycle of retreatment PRRT (R-PRRT) by March 31, 2025, will be enrolled in the study. Follow-up for these patients will be conducted until September 30, 2025, to assess their clinical outcomes.
Management information
Registered date
| 2025 | Year | 06 | Month | 03 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066370
