drugset / Trial / NCT04915144
177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is to assess if personalized peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATOC results in fewer adverse events than standard PRRT. Subjects will be randomized to either receive personalized or standard PRRT. Personalized PRRT will be determined based on dosimetry calculations after the first cycle. In addition comparisons, will be made with progression-free survival, serial CT imaging, ctDNA, and quality of life questionnaires. Subjects will be followed for 5 years or until they have progression and are switched to another systemic treatment (not including treatment with somatostatin analogues).
Timeline
- Start
- 2023-01-15
- Primary completion
- 2027-12-31
- Completion
- 2031-12-31
Outcome
Outcome not reported
Stopped: “Investigator decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lutetium Lu 177-Edotreotide | Peptide | 7400 mbq | Intravenous |