DOTA-TOC in Metastasized Neuroendocrine Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1499 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Neuroendocrine Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DOTA-TOC

Treatment arm

Group Type EXPERIMENTAL

DOTA-TOC Treatment

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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tetraazacyclododecanetetraacetic acid (DOTA) modified somatostatin analog Tyr3-octreotide (TOC)

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No