Surgical removal followed by targeted radiation therapy for neuroendocrine tumors

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy (PRRT) in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

This study is testing if surgery followed by a special radioactive treatment can help people with certain types of cancer that have spread to the liver.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vanderbilt-Ingram Cancer Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06016855 on ClinicalTrials.gov

What this trial studies

This phase IV trial evaluates the effectiveness of combining surgical debulking with peptide receptor radionuclide therapy (PRRT) using lutetium Lu 177 dotatate in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumors that have metastasized to the liver. Patients will undergo surgery to remove as much of the tumor as possible, followed by intravenous administration of the radioactive drug within 90 days. The study aims to measure the objective response rate, assess safety and tolerability, and analyze the tumor's genomic and radiomic profiles. Imaging studies will be conducted throughout the trial to monitor progress.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with well-differentiated grade 1 or 2 neuroendocrine tumors that have spread to the liver.

Not a fit: Patients with poorly differentiated neuroendocrine tumors or those without hepatic metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced gastroenteropancreatic neuroendocrine tumors.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

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

Where this trial is running

Nashville, Tennessee

• Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (RECRUITING)

Study contacts

• Principal investigator: Kamran Idrees, MD — Vanderbilt University/Ingram Cancer Center
• Study coordinator: Vanderbilt-Ingram Services for Timely Access

Conditions: Digestive System Neuroendocrine Tumor G1, Digestive System Neuroendocrine Tumor G2, Metastatic Digestive System Neuroendocrine Neoplasm, Metastatic Malignant Neoplasm in the Liver, Pancreatic Neuroendocrine Tumor G1, Pancreatic Neuroendocrine Tumor G2