Overview
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.
Description
Primary Objective(s)
- To assess feasibility and safety of combination of perioperative 177Lu Dotatate and cytoreductive surgery in metastatic GEP NETs Secondary Objective(s)
- To assess response rate (RR) after 2 cycles 177Lu Dotatate
- To assess recurrence free survival (RFS) of the overall treatment strategy
- To assess overall survival (OS) of the overall treatment strategy
Eligibility
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
- Patients on octreotide long-acting release (LAR) at a fixed dose of 20 mg or 30 mg at 3 to 4 weeks intervals for at least 12 weeks prior to enrollment in the study
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
- Known brain metastases
- Known bone or peritoneal metastases