A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours
Status:
Recruiting
Trial end date:
2033-12-01
Target enrollment:
Participant gender:
Summary
Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis is often delayed with
advanced metastases at presentation. In select patient populations, radioisotope therapy with
Lutetium-177 (Lu-DOTA-TATE) has been shown to be a safe and effective palliative therapy, and
has been widely used by research groups in Europe. A brand of Lu-DOTA-TATE (Lutathera(R)) is
approved for the treatment of gastroenteropancreatic NETs in Europe, the U.S., and more
recently in Canada. While Lutathera(R) is approved in Canada, it is not publicly funded in
Alberta. Lu-DOTA-TATE has been used at the Cross Cancer Institute to treat more than 300
patients with NETs since August, 2010. Our Lu-DOTA-TATE treatment was initially given under
Health Canada's Special Access Programme (SAP), with each individual treatment requiring
separate approval. In 2014, Health Canada requested we conduct a clinical trial with
Lu-DOTA-TATE instead.
The purpose of this study is to: 1) assess the efficacy of Lu-DOTA-TATE treatment in patients
with somatostatin receptor positive tumours; 2) assess the safety of Lu-DOTA-TATE; 3) assess
the effect of Lu-DOTA-TATE on Quality of Life and survival.