A phase III clinical trial investigating a new treatment option for advanced neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs)
Study to look at well-differentiated advanced Grade 2 and Grade 3 somatostatin receptor positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (G2 & G3 GEP-NETs)
Investigational treatment
Targeted Radionuclide Therapy with n.c.a. Lutetium-177-Edotreotide, consisting of the highly pure medical radioisotope, no-carrier-added (n.c.a.) Lutetium-177, used to destroy tumor cells, and the molecule Edotreotide, which targets neuroendocrine tumor-specific receptors and delivers the medical radioisotope to the tumor site.
What is Targeted Radionuclide Therapy?
In contrast to external radiotherapy, where radiation is applied from outside the body, Targeted Radionuclide Therapy isdefined by the infusion of a radiopharmaceutical into the body which precisely recognizes and destroys tumor cells while healthy surrounding tissue is minimally affected.
Comparator treatment
Standard therapy with either CAPTEM (chemotherapy) or everolimus (immunosuppressive cancer therapy) or FOLFOX (chemotherapy), determined by the doctor based on individual benefit-risk assessment and according to institutional protocols, local prescribing information, local regulations or local guidelines.
Study objectives
Evaluate efficacy, safety and impact on quality of life.
Contact
Peter MacCallum Cancer Centre
Melbourne VIC 3000, Australia
Principle Investigator: A/Prof Michael Michael
Contact: (03) 8559 5000
Royal North Shore Hospital
St Leonards / Sydney NSW 2065, Australia
Principle Investigator: A/Prof Nick Pavlakis
Contact: (02) 9926 7111
