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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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
Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi)
Medical Imaging
Medical Imaging
Medical Imaging
Stanford Cancer Institute Palo Alto
Stanford, California, United States
RECRUITINGMeasure 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)
Time frame: 6 months
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
Time frame: 16 weeks
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.
Time frame: 1 year
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.
Time frame: 1 year
gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
CONTACT
gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
CONTACT
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