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

Gastroenteropancreatic Neuroendocrine Tumor Clinical Trial

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

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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04609592
Study type Interventional
Source Stanford University
Contact Gino Pinedo
Phone 650-725-8474
Email gpineda@stanford.edu
Status Recruiting
Phase Phase 1
Start date March 17, 2021
Completion date September 2027
View Details
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