Clinical trial · Interventional
DOTA-TOC in Metastasized Neuroendocrine Tumors
Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DOTA-TOC Treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DOTA-TOC
- description
- Treatment arm
- interventionNames
- Drug: DOTA-TOC Treatment
Primary outcomes (1)
- measure
- Response
- timeFrame
- 3 months
Secondary outcomes (2)
- measure
- Toxicity
- timeFrame
- 3 months
- measure
- Survival
- timeFrame
- life-long
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDOtte A, Mueller-Brand J, Dellas S, Nitzsche EU, Herrmann R, Maecke HR. Yttrium-90-labelled somatostatin-analogue for cancer treatment. Lancet. 1998 Feb 7;351(9100):417-8. doi: 10.1016/s0140-6736(05)78355-0. No abstract available. PMID 9482300
- BACKGROUNDIten F, Muller B, Schindler C, Rochlitz C, Oertli D, Macke HR, Muller-Brand J, Walter MA. Response to [90Yttrium-DOTA]-TOC treatment is associated with long-term survival benefit in metastasized medullary thyroid cancer: a phase II clinical trial. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6696-702. doi: 10.1158/1078-0432.CCR-07-0935. PMID 18006770
- BACKGROUNDIten F, Muller B, Schindler C, Rasch H, Rochlitz C, Oertli D, Maecke HR, Muller-Brand J, Walter MA. [(90)Yttrium-DOTA]-TOC response is associated with survival benefit in iodine-refractory thyroid cancer: long-term results of a phase 2 clinical trial. Cancer. 2009 May 15;115(10):2052-62. doi: 10.1002/cncr.24272. PMID 19280592
- DERIVEDMarincek N, Jorg AC, Brunner P, Schindler C, Koller MT, Rochlitz C, Muller-Brand J, Maecke HR, Briel M, Walter MA. Somatostatin-based radiotherapy with [90Y-DOTA]-TOC in neuroendocrine tumors: long-term outcome of a phase I dose escalation study. J Transl Med. 2013 Jan 15;11:17. doi: 10.1186/1479-5876-11-17. PMID 23320604