UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057212 |
|---|---|
| Receipt number | R000065398 |
| Scientific Title | Multicenter Prospective Observational Study on the Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) Retreatment (R-PRRT) with 177Lu-DOTATATE for Neuroendocrine Neoplasms (NEN) |
| Date of disclosure of the study information | 2025/03/05 |
| Last modified on | 2025/03/05 14:19:31 |
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Basic information
Public title
Multicenter Prospective Observational Study on the Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) Retreatment (R-PRRT) with 177Lu-DOTATATE for Neuroendocrine Neoplasms (NEN)
Acronym
R-PRRT study
Scientific Title
Multicenter Prospective Observational Study on the Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) Retreatment (R-PRRT) with 177Lu-DOTATATE for Neuroendocrine Neoplasms (NEN)
Scientific Title:Acronym
R-PRRT study
Region
| Japan |
Condition
Condition
Neuroendocrine tumor
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the Efficacy of Peptide Receptor Radionuclide Therapy Retreatment (R-PRRT) with 177Lu-DOTATATE
Basic objectives2
Safety
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 by Primary Tumor Site, Disease Control Rate by Primary Tumor Site, Incidence of Major Hematologic Toxicities, Incidence of Nephrotoxicity, 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
1. Histologically confirmed diagnosis of neuroendocrine neoplasm (NEN) based on resected or biopsy specimens.
2. Unresectable or recurrent NEN.
3. History of four cycles of initial PRRT (I-PRRT) with 177Lu-DOTATATE, regardless of dosage.
4. Best overall response to I-PRRT was complete response (CR), partial response (PR), or stable disease (SD).
5. Radiological or clinical disease progression after the fourth cycle of I-PRRT, with PRRT retreatment considered clinically appropriate.
6. Adequate bone marrow function to undergo PRRT (hemoglobin >=7 g/dL, neutrophil count >=1,000/uL, platelet count >=50,000/mm3).
7. The Krenning score for target lesions on somatostatin receptor scintigraphy is over two.
8. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0-2.
9. Age at the time of informed consent is over 18.
10. Written informed consent obtained from the patient for study participation.
Key exclusion criteria
1. Patients who have received initial PRRT (I-PRRT) with 90Y-DOTATOC.
2. Patients who have undergone five or more, or fewer than three cycles of I-PRRT.
3. Patients deemed inappropriate for enrollment in this study at the discretion of the physician.
Target sample size
50
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 | 03 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter Prospective Observational Study
Management information
Registered date
| 2025 | Year | 03 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065398
