NCT04609592Active, not recruitingPhase 1
Study of PRRT in Metastatic, WHO Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 23 Oct 2020
- Start date
- 17 Mar 2021
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Stanford University
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT04609592
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 17 Mar 2021 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Known brain metastases
- Known bone or peritoneal metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford Cancer Institute Palo Alto Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.