DOTA-TOC in Metastasized Neuroendocrine Tumors
The investigators aim to explore the efficacy of [90Y-DOTA]-TOC and [177LuDOTA]-TOC therapy in advanced neuroendocrine cancer. Therefore, the investigators assess response, survival and long-term safety profile of systemic [90Y-DOTA]-TOC and [177LuDOTA]-TOC treatment in metastasized neuroendocrine cancer patients. Adverse events are assessed according to the criteria of the National Cancer Institute. Survival analyses are performed using multiple regression models.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Tumors|
- Response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Survival [ Time Frame: life-long ] [ Designated as safety issue: No ]
|Study Start Date:||September 1997|
|Study Completion Date:||December 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Drug: DOTA-TOC Treatment
Intravenous injections of DOTA-TOC. Repeated treatment cycles for responders, except in case of
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978211
|Basel, BS, Switzerland, 4031|
|Principal Investigator:||Martin A Walter, MD, Dr.||Institute of Nuclear Medicine; Inselspital Bern|