Actively Recruiting
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
Led by Stanford University · Updated on 2025-09-09
10
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) with 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera4) before and after surgery in patients with metastatic, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) classified as WHO Grade 1 or 2. This approach aims to increase overall survival and includes assessment of response rates, recurrence-free survival, and overall survival. Participants will undergo a treatment plan starting with two cycles of 177Lu Dotatate, followed by cytoreductive surgery, and then up to two additional cycles of 177Lu Dotatate for any remaining disease identified by 68Ga DOTA TATE PET/CT scans. The therapy involves specific dosing of the radioactive drug and is combined with standard imaging procedures including CT, MRI, and PET/CT scans to monitor disease and treatment effects. During the study, participants will be closely monitored for surgical complications within six months, response to treatment at 16 weeks, and long-term outcomes such as recurrence and survival over one year. Evaluations include imaging scans, laboratory tests to assess organ function, and performance status assessments. The study aims to gather comprehensive safety and effectiveness data on this perioperative treatment strategy over the course of participation, which may last at least a year based on survival outcome tracking.
CONDITIONS
Brief Title
Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic gastroenteropancreatic neuroendocrine tumor with lymph node or liver metastases only
- WHO Grade 1 or 2 tumor confirmed with Ki 67 64 20%
- Candidate for cytoreductive surgery aiming for R1 resection as determined by tumor board
- Measurable disease by RECIST v1.1 criteria
- Confirmed somatostatin receptor presence on all target lesions by 68Ga DOTA TATE PET scan
- Age 18 years or older
- ECOG performance status of 0 or 1
- Appropriate blood, liver, and kidney function
- Stable octreotide long-acting release treatment (20 or 30 mg) for at least 12 weeks prior to enrollment
You will not qualify if you...
- Prior treatment with 177Lu Dotatate
- Surgery or radiofrequency ablation within 12 weeks before enrollment, or prior radioembolization, chemoembolization, or external beam radiation covering more than 25% of bone marrow
- Chemotherapy or targeted therapy within 4 weeks before enrollment
- Known brain metastases
- Known bone or peritoneal metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 16 weeks
Participants receive 2 cycles of 177Lu Dotatate drug therapy, followed by cytoreductive surgery, and then up to 2 additional cycles of 177Lu Dotatate if residual disease is detected.
Multiple visits for drug infusions and surgery
Duration - Up to 1 year
Participants are monitored for response to treatment, recurrence-free survival, and overall survival through imaging and clinical assessments.
Periodic visits for imaging and assessments
Trial Site Locations
Total: 1 location
1
Stanford Cancer Institute Palo Alto
Stanford, California, United States, 95304
Actively Recruiting
Research Team
G
gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
G
gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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