UMIN ID: UMIN000054127
Registered date:12/04/2024
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).
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Unresectable neuroendocrine tumors (NEN) |
| Date of first enrollment | 2024/04/12 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Objective response rate |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | None |
Related Information
| Primary Sponsor | National cancer center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) | JON2203-N |
Contact
| public contact | |
| Name | Kohei Okamoto |
| Address | 5-1-1 Tsukiji, Chuo, Tokyo, Japan Japan 104-0045 |
| Telephone | 81-3-3542-2511 |
| kookamot@ncc.go.jp | |
| Affiliation | National cancer center hospital Hepatobiliary and pancreatic oncology |
| scientific contact | |
| Name | Susumu Hijioka |
| Address | 5-1-1 Tsukiji, Chuo, Tokyo, Japan Japan |
| Telephone | 81-3-3542-2511 |
| shijioka@ncc.go.jp | |
| Affiliation | National cancer center hospital Hepatobiliary and pancreatic oncology |