Study of PRRT in Metastatic World Health Organization (WHO) Grade 1 or 2 SSTR Positive GEP-NET Who Are Candidates for Cytoreductive Surgery

  • STATUS
    Recruiting
  • End date
    Sep 27, 2027
  • participants needed
    10
  • sponsor
    Stanford University
Updated on 27 April 2021

Summary

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.

Description

Primary Objective(s)

  • To assess feasibility and safety of combination of perioperative 177Lu Dotatate and cytoreductive surgery in metastatic GEP NETs Secondary Objective(s)
  • To assess response rate (RR) after 2 cycles 177Lu Dotatate
  • To assess recurrence free survival (RFS) of the overall treatment strategy
  • To assess overall survival (OS) of the overall treatment strategy

Details
Condition Gastroenteropancreatic Neuroendocrine Tumor
Treatment Magnetic Resonance Imaging (MRI), PET/CT, Computed Tomography (CT), LUTATHERA, Gallium 68 Dotatate, Gallium 68 Dotatate
Clinical Study IdentifierNCT04609592
SponsorStanford University
Last Modified on27 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Known brain metastases
Known bone or peritoneal metastases
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