Status: Open
Activation Date: 2023JUN05
Phase: II
Description: NET RETREAT: A Phase II Study of 177Lutetium- DOTATATE Retreatment vs. Everolimus in Metastatic/unresectable Midgut NET
Eligibility: At least 18 years of age. Metastatic, histologically confirmed Grade 1 or 2 well-differentiated midgut NET with positive Gallium 68 DOTATATE or Copper 64 DOTATATE scan (SUVmax of target lesion is > SUV mean of normal liver parenchyma) within 36 months (within 12 months is preferred). Have received 3 or 4 cycles of PRRT. Have had progression per RECIST 1.1 after prior PRRT and no sooner than 12 months from last scan post initial PRRT completion where either stable disease, partial response, or complete response has been maintained. Have not received intervening therapy. No ongoing toxicity from prior PRRT that is Grade 3 or higher according to CTCAE 5.0. ECOG performance status </=2. Prior or current use of somatostatin analogues is allowed for carcinoid syndrome control. No prior alkylator alpha therapy is permitted. Patients of childbearing potential must agree to use highly effective contraception during treatment and for 7 months after. Must have access to everolimus.
Objective: Primary Objective: Progression-free survival Secondary Objectives: toxicity and safety, overall response rate, overall survival, post progression survival and time to second objective disease progression for crossover patients, quality of life
Lay Description: The purpose of this study is to find out whether retreatment with Peptide Receptor Radionuclide Therapy (PRRT) using Lutetium 177 dotatate can slow the growth of well-differentiated Grade 1 and Grade 2 metastatic midgut neuroendocine tumours compared to the usual approach of everollimus.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GASTRO-INTESTINAL | NE1 | Open Trial | 0 | 0 | 0 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GASTRO-INTESTINAL | NE1 | Open Trial | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GASTRO-INTESTINAL | NE1 | Open Trial | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |