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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).

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). - 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).

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000054127
Enrollment
200
Registered
2024-04-12
Start date
2024-04-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable neuroendocrine tumors (NEN)

Interventions

None listed

Sponsors

National cancer center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Objective response rate

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactKohei Okamoto

National cancer center hospital Hepatobiliary and pancreatic oncology

kookamot@ncc.go.jp81-3-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026