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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
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: DOTA-TOC Treatment Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1499 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of [90Y-DOTA]-TOC and [177Lu-DOTA]-TOC in Metastasized Neuroendocrine Tumors
Study Start Date : September 1997
Primary Completion Date : September 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: DOTA-TOC
Treatment arm
Drug: DOTA-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.
Other Names:
  • tetraazacyclododecanetetraacetic acid (DOTA) modified
  • somatostatin analog Tyr3-octreotide (TOC)

Primary Outcome Measures :
  1. Response [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 3 months ]
  2. Survival [ Time Frame: life-long ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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

University Hospital
Basel, BS, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Martin A Walter, MD, Dr. Institute of Nuclear Medicine; Inselspital Bern

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00978211     History of Changes
Other Study ID Numbers: MAW002
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by University Hospital, Basel, Switzerland:

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neoplasm Metastasis
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplastic Processes
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents