Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Cancer
Background: Systemic treatment with the 90Yttrium (90Y) labeled,
tetraazacyclododecanetetraacetic acid (DOTA) modified somatostatin analog Tyr3-octreotide
(TOC) was introduced in 1998 (Otte et al. Lancet 1998). [90Y-DOTA]-TOC is administered
intravenously and binds to the somatostatin receptor subtype 2, located on the surface of
the tumor cell, and exerts its cytotoxic effects by β-irradiation. The treatment has
moderate acute hematologic and nephrologic toxicity and has developed into a promising
therapeutic tool for tumors expressing its target receptor (Iten et al. Clin Cancer Res
2007, Iten et al. Cancer 2009).
Study Aim: To explore the efficacy of [90Y-DOTA]-TOC and [177LuDOTA]-TOC therapy in advanced
neuroendocrine cancer.
Study Hypothesis: Response to DOTA-TOC is correlated with prolonged survival.
Study Type: Clinical phase II, single-center, open-label trial
Patients: 1500 patients
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response
3 months
No
Martin A Walter, MD
Principal Investigator
Institute of Nuclear Medicine
Switzerland: Federal Office of Public Health
MAW002
NCT00978211
September 1997
May 2014
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