Using targeted radiation therapy before and after surgery for certain neuroendocrine tumors

Pilot Phase 1 Study of Perioperative Peptide Receptor Radionuclide Therapy (PRRT) in Metastatic, WHO Grade 1 or 2, SSTR Positive, Gastroenteropancreatic Neuroendocrine Tumors Who Are Candidates for Cytoreductive Surgery

This study is testing if a special type of radiation therapy before and after surgery can help people with advanced neuroendocrine tumors live longer and have fewer recurrences.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (other)
• Drugs / interventions: sunitinib, chemotherapy, radiation
• Locations: 1 site (Stanford, California)
• Trial ID: NCT04609592 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and feasibility of Peptide Receptor Radionuclide Therapy (PRRT) using Lutathera before and after cytoreductive surgery in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The primary objective is to assess the combination's effectiveness in improving overall survival and recurrence-free survival. Patients will receive two cycles of 177Lu Dotatate and undergo imaging assessments to monitor treatment response. The study aims to determine if this approach can enhance surgical outcomes for eligible patients.

Who should consider this trial

Good fit: Ideal candidates include adults with metastatic GEP-NETs who are eligible for cytoreductive surgery and have confirmed somatostatin receptors on their tumors.

Not a fit: Patients who have previously received 177Lu Dotatate treatment or have undergone recent surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with metastatic GEP-NETs.

How similar studies have performed: Previous studies have shown promising results with PRRT in similar patient populations, indicating potential for success in this approach.

Eligibility 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

Where this trial is running

Stanford, California

• Stanford Cancer Institute Palo Alto — Stanford, California, United States (RECRUITING)

Study contacts

• Principal investigator: Brendan C Visser, MD — Stanford Universiy
• Study coordinator: [e-mail] [e-mail]

Conditions: Gastroenteropancreatic Neuroendocrine Tumor