Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET… (NCT04609592) | Clinical Trial Compass
RecruitingPhase 1
Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
United States10 participantsStarted 2021-03-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only.
✓. WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford)
✓. Must be a candidate for cytoreductive surgery with the goal of R1 resection as determined by a multidisciplinary tumor board discussion
✓. Measurable disease as determined by RECIST v1.1
✓. Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan
✓. Patients ≥ 18 years of age.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
✓. Appropriate hematologic, liver and kidney function
Exclusion criteria
✕. Prior 177Lu Dotatate treatment
✕. Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (EBRT) to \> 25% of bone marrow, at any time
✕. Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to enrollment in the study