Clinical trial · Interventional
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors
- 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)
This phase IV trial evaluates how well giving standard of care (SOC) peptide receptor radionuclide therapy (PRRT) after SOC surgical removal of as much tumor as possible (debulking surgery) works in treating patients with grade 1 or 2, somatostatin receptor (SSTR) positive, gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have spread from where they first started (primary site) to the liver (hepatic metastasis). Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells. Lutetium Lu 177 dotatate includes a radioactive form (an isotope) of the element called lutetium. This radioactive isotope (Lu-177) is attached to a molecule called dotatate. On the surface of GEP-NET tumor cells, a receptor called a somatostatin receptor binds to dotatate. When this binding occurs, the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells, and radiation emitted by Lu-177 helps kill the cells. Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 1/2 GEP-NETs
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Digestive System Neuroendocrine Tumor G1 | Digestive System Neuroendocrine Tumor G1 | ONTOLOGY_EXACT | 0.98 |
| Digestive System Neuroendocrine Tumor G2 | Digestive System Neuroendocrine Tumor G2 | ONTOLOGY_EXACT | 0.98 |
| Metastatic Digestive System Neuroendocrine Neoplasm | Digestive System Neuroendocrine Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Malignant Neoplasm in the Liver | — | UNRESOLVED | — |
| Pancreatic Neuroendocrine Tumor G1 | Pancreatic Neuroendocrine Tumor G1 | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neuroendocrine Tumor G2 | Pancreatic Neuroendocrine Tumor G2 | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Copper Cu 64 Dotatate | Drug | — | UNRESOLVED |
| Lutetium Lu 177 Dotatate | Drug | Lutetium (177lu) Oxodotreotide | ALIAS |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Tumor Debulking | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (surgical debulking, 177Lu dotatate)
- description
- Patients undergo surgical debulking on day 0 and receive 177Lu dotatate IV over 30 to 40 minutes on day 1 of each cycle. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI throughout the trial, and undergo dotatate PET/CT during screening and on study.
- interventionNames
- Procedure: Tumor Debulking
- Drug: Lutetium Lu 177 Dotatate
- Procedure: Computed Tomography
- Procedure: Magnetic Resonance Imaging
- Drug: Copper Cu 64 Dotatate
- Procedure: Positron Emission Tomography
Primary outcomes (6)
- measure
- Somatostatin receptor standardized uptake values (SSTR SUV)
- timeFrame
- Up to 2 years
- description
- SSTR SUV (not limited to but including measures such as SSTR SUV max, SSTR SUV mean) will be estimated for the patients undergoing post-operative research dotatate scans and compared to values from peptide receptor radionuclide therapy (PRRT) eligibility-conferring dotatate scans in these same patients. These quantitative analytics will be performed by central review. Changes in SSTR SUV values will be analyzed with summary statistics.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed and dated written informed consent * Male or female \>= 18 years of age on the day of signing informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Histologically confirmed well-differentiated gastrointestinal or pancreatic neuroendocrine tumor that is grade 1 or grade 2 (Ki-67 =\< 20%) * Somatostatin receptor avidity of known or suspected neuroendocrine tumor (NET) lesion(s) assessed by a baseline copper-64 dotatate PET/CT scan performed within 6 months (180 days) prior to surgical debulking on study day 0. The somatostatin receptor avidity of the majority of suspected NET lesion(s) must be \>= normal liver uptake * Patient must have hepatic metastasis or hepatic metastases. Provided required hepatic metastatic disease is present, patient can also have any other site or sites of metastatic disease * White blood cell count (WBC) \>= 2000/uL (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study) * Platelets \>= 75,000/uL (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study) * Hemoglobin \>= 8.0 g/dL (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study) * Creatinine clearance (CrCl) \>= 30 mL/minute (as calculated by the Cockcroft-Gault Formula with estimated creatinine clearance rate \[eCCR\] \>= 30 mL/min required for eligibility inclusion; or calculated/measured by an alternative established institutional standard consistently applied across participants at the site) (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study) * Total bilirubin =\< 3.0 times institutional upper limit of normal (ULN) (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study) * Serum albumin \>= 3.0 g/dL unless the prothrombin time is within normal range (resulted =\< 90 days prior to surgical debulking on day 0 of participation in this study) * Women must not be breastfeeding and further agree to not breastfeed during treatment with lutetium Lu 177 dotatate; and for at least 2.5 months after patient's final dose of lutetium Lu 177 dotatate * A woman of childbearing potential (WOCBP) - must have a negative serum or urine pregnancy test resulted within 28 days prior to initiation of first dose of lutetium Lu 177 dotatate on cycle 1, day 1; and must agree to follow instructions for using acceptable contraception from the time of signing consent, and until 7 months after her final dose of lutetium Lu 177 dotatate * A man able to father children who is sexually active with a WOCBP must agree to follow instructions for using acceptable contraception, from the time of signing consent, and until 4 months after his final dose of lutetium Lu 177 dotatate Exclusion Criteria: * Patient has any tumor \> 3 cm deemed to be inoperable * Patient has disease which is considered to be completely surgically resectable * Patient has grade 3 neuroendocrine neoplasm (well-differentiated or poorly-differentiated tumor) * Prior receipt of peptide receptor radionuclide therapy (PRRT) * Patient possesses untreated or growing brain metastases (growth within 90 days prior to surgical debulking on day 0 of participation in this study) * Unstable angina, congestive heart failure with New York Heart Association (NYHA) functional classification III or IV, or uncontrolled symptomatic cardiac arrythmia * Any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which in the judgment of the patient's study physician may reasonably be expected to interfere with patient's completion of the study
References
Publications (1)
- DERIVEDvon Hessert-Vaudoncourt C, Maasberg S, Begum N, Rinke A, Poppel T, Sipos B, Grohe C, Fottner C, Stintzing S, Grabowski P; German NET Registry. Clinical characteristics and treatment patterns of patients with gastroenteropancreatic neuroendocrine neoplasia in Germany receiving peptide receptor radionuclide therapy: A real-world data registry-based study. Medicine (Baltimore). 2025 Mar 14;104(11):e41853. doi: 10.1097/MD.0000000000041853. PMID 40101049