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A prospective, randomized, Controlled, Open-label, Multicenter phase III study to evaluate efficacy and safety of PEptide Receptor Radionuclide Therapy (PRRT) with 177Lu-edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs).
COMPETE is an international, prospective (new data to be collected), randomized (patients randomly assigned by a computerized system to investigational or standard therapy group), controlled (investigational group compared to control group), open-label (patients and physicians know which drug is administered), multicenter phase III study to evaluate the efficacy and safety of Targeted Radionuclide Therapy with n.c.a. lutetium-177-edotreotide compared to everolimus in patients with grade 1 or grade 2 somatostatin receptor-positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs).
Investigational medicinal treatment:
Targeted Radionuclide Therapy with n.c.a. lutetium-177-edotreotide
N.c.a. lutetium-177-edotreotide consists of the highly pure medical radioisotope, no-carrier-added (n.c.a.) lutetium-177 used to destroy the tumor cells by emitting a small amount of radiation, and the targeting molecule edotreotide, a synthetic form of the peptide hormone somatostatin that targets neuroendocrine tumor-specific receptors and places the medical radioisotope directly onto the diseased neuroendocrine cells. The highly precise localization can result in the healthy tissue surrounding the targeted tumor being minimally affected.
Active comparator treatment:
Everolimus, an immunosuppressive cancer therapy, established as one of the current standard of care treatments for GEP-NETs.
Evaluate the efficacy and safety of Targeted Radionuclide Therapy with n.c.a. lutetium-177-edotreotide compared to everolimus in patients with grade 1 or grade 2 GEP-NETs.
The study has been evaluated favorably by the responsible ethics committee and has been approved by the responsible authority.
Please also see COMPETE study information on clinicaltrials.gov, Identifier: NCT03049189