Neuroendocrine tumor
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYasuhiro Komori
National Cancer Center Hospital Department of Hepatobiliary and Pancreatic Oncology
Outcome results
None listed