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Recruiting NCT04609592

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

Phase I Interventional Gastroenteropancreatic Neuroendocrine Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lutathera, Gallium 68 Dotatate, Computed Tomography (CT), Magnetic Resonance Imaging (MRI).
Who it may be relevant to
Registry conditions: Gastroenteropancreatic Neuroendocrine Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

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

Interventions

  • Drug 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
  • Drug Gallium 68 Dotatate
    Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi)
  • Procedure Computed Tomography (CT)
    Medical Imaging
  • Procedure Magnetic Resonance Imaging (MRI)
    Medical Imaging
  • Procedure PET/CT
    Medical Imaging

Primary outcome measures

  • Measure Complication free Surgery [Time frame: 6 months]
Secondary outcome measures (3)
  • Response Rate (RR) [Time frame: 16 weeks]
  • Recurrence free Survival (RFS) [Time frame: 1 year]
  • Overall Survival (OS) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only.
  • WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford)
  • Must be a candidate for cytoreductive surgery with the goal of R1 resection as determined by a multidisciplinary tumor board discussion
  • Measurable disease as determined by RECIST v1.1
  • Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan
  • Patients ≥ 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1
  • Appropriate hematologic, liver and kidney function
  • 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

  • Prior 177Lu Dotatate treatment
  • 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
  • Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to enrollment in the study
  • Known brain metastases
  • Known bone or peritoneal metastases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford Cancer Institute Palo Alto — Stanford

Identifiers

NCT: NCT04609592 · IRB-52341 · NET0030 · NCI-2021-03448

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗