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

Description

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

Gastroenteropancreatic Neuroendocrine Tumor

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Study Overview

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Study Details

Study overview

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.

Pilot 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

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

Condition
Gastroenteropancreatic Neuroendocrine Tumor
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford Cancer Institute Palo Alto, Stanford, California, United States, 95304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Brendan C Visser, MD, PRINCIPAL_INVESTIGATOR, Stanford Universiy

Study Record Dates

2027-09