drugset / Trial / NCT05459844
A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs
RandomizedParallel-groupOpen-labelTreatment
Summary
This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutetium\[177Lu\] Oxodotreotide Injection to high dose (60 mg) Octreotide LAR in patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.
Timeline
- Start
- 2022-08-31
- Primary completion
- 2024-06-26
- Completion
- 2028-12
Publications
- Liu F, Yang H, Zhang J, Li J, Qiao Y, Chen J, Song S. Relationship between absorbed dose and SUV derived from SPECT/CT imaging and dose-response in patients with neuroendocrine tumors treated with [(1)(7)(7)Lu]Lu-DOTA-TATE. EJNMMI Res. 2026 Feb 25;16(1):52. doi: 10.1186/s13550-026-01402-2.
- Liu F, Li P, Xu J, Zhang J, Xu X, Chen Z, Qiao Y, Liang Y, Chen J, Song S. Radiation exposure and protection advice after [177Lu]Lu-DOTA-TATE therapy in China. EJNMMI Res. 2024 Nov 28;14(1):119. doi: 10.1186/s13550-024-01185-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-DOTATATE | Peptide | 7400 mbq | — |
| Comparator | Octreotide | Peptide | 60 mg | Intramuscular |