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

NCT ID: NCT04609592

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2027-09-30

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

Conditions

Gastroenteropancreatic Neuroendocrine Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lutathera

2 cycles of 177Lu Dotatate, followed by cytoreductive surgery, followed by additional 177Lu Dotatate (up to 2 cycles) for residual disease as determined by 68Ga DOTA TATE PET/CT

Group Type: EXPERIMENTAL

Lutathera

Intervention Type: DRUG

4 administrations of 7.4 gigabecquerel (GBq) (200 mCi) 177Lu Dotatate +/ 10% at the date and time of infusion, accumulative dose of 29.6 GBq (800 mCi). T

Gallium 68 Dotatate

Intervention Type: DRUG

Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi)

Computed Tomography (CT)

Intervention Type: PROCEDURE

Medical Imaging

Magnetic Resonance Imaging (MRI)

Intervention Type: PROCEDURE

Medical Imaging

PET/CT

Intervention Type: PROCEDURE

Medical Imaging

Interventions

Lutathera

4 administrations of 7.4 gigabecquerel (GBq) (200 mCi) 177Lu Dotatate +/ 10% at the date and time of infusion, accumulative dose of 29.6 GBq (800 mCi). T

Intervention Type: DRUG

Gallium 68 Dotatate

Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi)

Intervention Type: DRUG

Computed Tomography (CT)

Medical Imaging

Intervention Type: PROCEDURE

Magnetic Resonance Imaging (MRI)

Medical Imaging

Intervention Type: PROCEDURE

PET/CT

Medical Imaging

Intervention Type: PROCEDURE

Other Intervention Names

lutetium Lu 177 dotatate; (Lu 177)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10- tetraazacyclododec-1-yl) acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-Lcysteinyl-L-threonine-cyclic (2-7) disulfide.; 177 Lu-DOTA-octreotate; Gallium-68 DOTA-DPhe1, Tyr3-octreotate; CT Scan; Positron Emission Tomography (PET)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brendan C Visser, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Universiy

Locations

Stanford Cancer Institute Palo Alto

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu

Role: CONTACT

gpineda@stanford.edu

(650) 498-7757

gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu

Role: CONTACT

gitrialeligibility@stanford.edu

(650) 498-7757

Facility Contacts

Role: primary

gitrialeligibility@stanford.edu

Other Identifiers

NET0030

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2021-03448

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB-52341

Identifier Type: -

Identifier Source: org_study_id