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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04609592
Other study ID # IRB-52341
Secondary ID NET0030NCI-2021-
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 17, 2021
Est. completion date September 2027

Study information

Verified date January 2024
Source Stanford University
Contact Gino Pinedo
Phone 650-725-8474
Email gpineda@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date September 2027
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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
Magnetic Resonance Imaging (MRI)
Medical Imaging
PET/CT
Medical Imaging

Locations

Country Name City State
United States Stanford Cancer Institute Palo Alto Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure Complication free Surgery 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)
6 months
Secondary Response Rate (RR) 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
16 weeks
Secondary Recurrence free Survival (RFS) 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. 1 year
Secondary Overall Survival (OS) 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. 1 year
See also
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Completed NCT04852679 - Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs Phase 3
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Active, not recruiting NCT05262556 - NP-101 (TQ Formula) With Nivolumab and Ipilimumab in Advanced or Metastatic Extra-pulmonary Neuroendocrine Carcinomas Phase 1
Completed NCT03017690 - Lanreotide and Octreotide Long Acting Release (LAR) for Patients With Advanced Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)