DOTA-TOC in Metastasized Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT00978211|
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : August 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: DOTA-TOC Treatment||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1499 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Tumors|
|Study Start Date :||September 1997|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||December 2013|
Drug: DOTA-TOC Treatment
Intravenous injections of DOTA-TOC. Repeated treatment cycles for responders, except in case of
- Response [ Time Frame: 3 months ]
- Toxicity [ Time Frame: 3 months ]
- Survival [ Time Frame: life-long ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978211
|Basel, BS, Switzerland, 4031|
|Principal Investigator:||Martin A Walter, MD, Dr.||Institute of Nuclear Medicine; Inselspital Bern|