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Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

ConditionsDigestive System Neuroendocrine Tumor G1Digestive System Neuroendocrine Tumor G2Metastatic Digestive System Neuroendocrine NeoplasmMetastatic Malignant Neoplasm in the LiverPancreatic Neuroendocrine Tumor G1Pancreatic Neuroendocrine Tumor G2
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%)

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Tumor Debulking

    Procedure/Surgery

    Undergo surgical debulking

  • Lutetium Lu 177 Dotatate

    Drug

    Given by IV

  • Computed Tomography

    Procedure/Surgery

    Undergo Computed Tomography

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo Magnetic Resonance Imaging

  • Copper Cu 64 Dotatate

    Drug

    Given by IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo Positron Emission Tomography

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Treatment (surgical debulking, 177Lu dotatate)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Somatostatin receptor standardized uptake values (SSTR SUV)

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.

Time frame
Up to 2 years
2

Progression-free survival

Will be estimated by the Kaplan-Meier method.

Time frame
From the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years
3

Overall response rate

Will be estimated by measuring the number of patients who achieve a complete response or partial response by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria on restaging computed tomography or magnetic resonance imaging scans =\< 6 months from PRRT completion, from the total number of patients who received the study treatment and possessed measurable disease post-surgical debulking. The number of patients who possessed measurable disease which did not meet RECIST 1.1 eligibility criteria post-surgical debulking will also be recorded.

Time frame
Up to 2 years
4

Overall survival

Will be estimated by the Kaplan-Meier method.

Time frame
From the start of PRRT to the date the patient progresses radiographically or succumbs to the disease, assessed up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt-Ingram Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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