Clinical trial NCT04609592: Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Gastroenteropancreatic Neuroendocrine Tumor
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2020-10-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: Inclusion 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

Exclusion Criteria:

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

Primary outcomes:
measure: Measure Complication free Surgery
timeFrame: 6 months
Secondary outcomes:
measure: Response Rate (RR)
timeFrame: 16 weeks
measure: Recurrence free Survival (RFS)
timeFrame: 1 year
measure: Overall Survival (OS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Cancer Institute Palo Alto
state: California
Study officials:
affiliation: Stanford Universiy
name: Brendan C Visser, MD
role: PRINCIPAL_INVESTIGATOR
References: