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| ID | Type | Description | Link |
|---|---|---|---|
| NET0030 | Other Identifier | OnCore | |
| NCI-2021-03448 | Registry Identifier | CTRP |
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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The purpose of this study is to learn about the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) before and after surgical removal of a tumor. PRRT treatment is based on the administration of a radioactive product, 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors GEP-NETs.
Primary Objective(s)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lutathera | Experimental | 2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutathera | Drug | 4 administrations of 7.4 gigabecquerel (GBq) (200 mCi) 177Lu Dotatate +/ 10% at the date and time of infusion, accumulative dose of 29.6 GBq (800 mCi). T |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure Complication free Surgery | The feasibility of perioperative 177Lu Dotatate as part of the therapeutic regimen to treat metastatic neuroendocrine tumors (NETs) will be assessed on the basis of number and proportion of participants who undergo 2 cycles of complication free 177Lu Dotatate therapy followed by cytoreductive surgery without complications, expressed as a number without dispersion. Complications are defined as follows.
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (RR) | Response Rate (RR), as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, will be determined after 2 pre operative cycles of 177Lu Dotatate. RR will be assessed as the sum of complete response (CR) and partial response (PR), and expressed as a number without dispersion. RECIST criteria are:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu | Contact | (650) 498-7757 | gpineda@stanford.edu | |
| gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu | Contact | (650) 498-7757 | gitrialeligibility@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brendan C Visser, MD | Stanford Universiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute Palo Alto | Recruiting | Stanford | California | 95304 | United States |
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|
| Gallium 68 Dotatate | Drug | Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi) |
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| Computed Tomography (CT) | Procedure | Medical Imaging |
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| Magnetic Resonance Imaging (MRI) | Procedure | Medical Imaging |
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| PET/CT | Procedure | Medical Imaging |
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| 16 weeks |
| Recurrence free Survival (RFS) | Recurrence free Survival (RFS) is defined as the number and proportion of participants that remain alive from the start of treatment without relapse or recurrence of disease, expressed as a number without dispersion. | 1 year |
| Overall Survival (OS) | Overall survival (OS) is defined as the number and proportion of participants that remain alive from the start of treatment, expressed as a number without dispersion. | 1 year |
| ID | Term |
|---|---|
| C535650 | Gastro-enteropancreatic neuroendocrine tumor |
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| ID | Term |
|---|---|
| C447941 | lutetium Lu 177 dotatate |
| D004220 | Disulfides |
| C513399 | gallium Ga 68 dotatate |
| C499142 | Ga(III)-DOTATOC |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013440 | Sulfides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006862 | Hydrogen Sulfide |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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