Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04609592

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Gastroenteropancreatic Neuroendocrine Tumor Gastro-enteropancreatic neuroendocrine tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford Cancer Institute Palo Alto

Stanford, California, 95304, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lutathera

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

Other 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 Dotatate

Drug

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

Other names: Gallium-68 DOTA-DPhe1, Tyr3-octreotate

Computed tomography (CT)

Procedure

Medical Imaging

Other names: CT Scan

Magnetic Resonance Imaging (MRI)

Procedure

Medical Imaging

PET/CT

Procedure

Medical Imaging

Other names: Positron Emission Tomography (PET)

Primary outcomes

  1. Measure Complication free Surgery

    Time frame: 6 months

    The feasibility of perioperative 177Lu Dotatate as part of the therapeutic regimen to treat metastatic neuroendocrine tumors (NETs) will be assessed on the basis of number and proportion of participants who undergo 2 cycles of complication free 177Lu Dotatate therapy followed by cytoreductive surgery without complications, expressed as a number without dispersion. Complications are defined as follows.

    • Radiation fibrosis
    • Hepatic fibrosis by histologic diagnosis
    • Hepatic insufficiency
    • Bowel anastamotic leak (if bowel surgery)
    • Distal pancreatic leak (if pancreas surgery)

Secondary outcomes

  1. Response Rate (RR)

    Time frame: 16 weeks

    Response Rate (RR), as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, will be determined after 2 pre operative cycles of 177Lu Dotatate. RR will be assessed as the sum of complete response (CR) and partial response (PR), and expressed as a number without dispersion. RECIST criteria are:

    • CR = Disappearance of all target lesions
    • PR = ≥ 30% decrease in the sum of the longest diameter of target lesions
    • Response Rate (RR) = CR + PR
    • Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)
    • Stable disease (SD) = Small changes that do not meet any of the above criteria

  2. Recurrence free Survival (RFS)

    Time frame: 1 year

    Recurrence free Survival (RFS) is defined as the number and proportion of participants that remain alive from the start of treatment without relapse or recurrence of disease, expressed as a number without dispersion.

  3. Overall Survival (OS)

    Time frame: 1 year

    Overall survival (OS) is defined as the number and proportion of participants that remain alive from the start of treatment, expressed as a number without dispersion.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 30, 2020
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.