Skip to main content
OpenTrials
Completed

NCT Number: NCT00978211

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DOTA-TOC Treatment

Drug

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.

Other names: tetraazacyclododecanetetraacetic acid (DOTA) modified, somatostatin analog Tyr3-octreotide (TOC)

Primary outcomes

  1. Response

    Time frame: 3 months

Secondary outcomes

  1. Toxicity

    Time frame: 3 months

  2. Survival

    Time frame: life-long

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Tumors

Important dates

Study start
1997
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2009
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.