Overview

Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery

Status:
Recruiting
Trial end date:
2027-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stanford University
Collaborators:
Advanced Accelerator Applications
Novartis Pharmaceuticals
Treatments:
Lutetium Lu 177 dotatate
Criteria
Inclusion Criteria:

1. Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only.

2. WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford)

3. Must be a candidate for cytoreductive surgery with the goal of R1 resection as
determined by a multidisciplinary tumor board discussion

4. Measurable disease as determined by RECIST v1.1

5. Confirmed presence of somatostatin receptors on all target lesions as determined by
68Ga DOTA TATE PET scan

6. Patients ≥ 18 years of age.

7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1

8. Appropriate hematologic, liver and kidney function

9. 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:

1. Prior 177Lu Dotatate treatment

2. 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

3. Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4
weeks prior to enrollment in the study

4. Known brain metastases

5. Known bone or peritoneal metastases