RECRUITING

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

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-03-17

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04609592

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu

CONTACT

(650) 498-7757

gpineda@stanford.edu

gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu

CONTACT

(650) 498-7757

gitrialeligibility@stanford.edu

Principal Investigator

Brendan C Visser, MD

PRINCIPAL_INVESTIGATOR

Stanford Universiy

Study Locations (Sites)

Stanford Cancer Institute Palo Alto

Stanford, California, 95304

United States

Collaborators and Investigators

Sponsor: Stanford University

Brendan C Visser, MD, PRINCIPAL_INVESTIGATOR, Stanford Universiy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-17

Study Completion Date2027-09

Study Record Updates

Study Start Date2021-03-17

Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

Gastroenteropancreatic Neuroendocrine Tumor