Neuroendocrine Tumors
Conditions
Keywords
DOTATOC, somatostatin, radiopeptide, Yttrium, Lutetium, neuroendocrine, cancer
Brief summary
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.
Detailed description
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
Interventions
DRUGDOTA-TOC Treatment
Intravenous injections of DOTA-TOC. Repeated treatment cycles for responders, except in case of * renal toxicity * loss of patient transferability or * denial of further treatment.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* histologically confirmed neuroendocrine cancer * stage IVc disease by definition of the American Joint Committee on Cancer, i.e. occurrence of distant metastases * visible tumor uptake in the pretherapeutic somatostatin receptor subtype 2 scintigraphy (111In-Octreoscan)
Exclusion criteria
* concurrent anti-tumor treatment * secondary malignancies * pregnancy * breast-feeding * incontinence * severe concomitant illness including severe psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | 3 months |
| Survival | life-long |
Countries
Switzerland
Outcome results
None listed