Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumor | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography (CT) | Procedure | — | UNRESOLVED |
| Gallium 68 Dotatate | Drug | — | UNRESOLVED |
| Lutathera | Drug | Lutetium (177lu) Oxodotreotide | ALIAS |
| Magnetic Resonance Imaging (MRI) | Procedure | — | UNRESOLVED |
| PET/CT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lutathera
- description
- 2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT
- interventionNames
- Drug: Lutathera
- Drug: Gallium 68 Dotatate
- Procedure: Computed Tomography (CT)
- Procedure: Magnetic Resonance Imaging (MRI)
- Procedure: PET/CT
Primary outcomes (1)
- measure
- Measure Complication free Surgery
- timeFrame
- 6 months
- description
- The feasibility of perioperative 177Lu Dotatate as part of the therapeutic regimen to treat metastatic neuroendocrine tumors (NETs) will be assessed on the basis of number and proportion of participants who undergo 2 cycles of complication free 177Lu Dotatate therapy followed by cytoreductive surgery without complications, expressed as a number without dispersion. Complications are defined as follows. * Radiation fibrosis * Hepatic fibrosis by histologic diagnosis * Hepatic insufficiency * Bowel anastamotic leak (if bowel surgery) * Distal pancreatic leak (if pancreas surgery)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available