Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2013-12-31

Brief Summary

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Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut

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Detailed Description

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Conditions

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Neuroendocrine Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Octreotide LAR (Long Acting Release)

Octreotide LAR 30 mg intramuscularly every 28 days

Group Type EXPERIMENTAL

Octreotide LAR (Long-acting release)

Intervention Type DRUG

30 mg intramuscularly every 28 days

Placebo

Placebo - Sodium chloride intramuscularly every 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sodium chloride intramuscularly every 28 days

Interventions

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Octreotide LAR (Long-acting release)

30 mg intramuscularly every 28 days

Intervention Type DRUG

Placebo

Sodium chloride intramuscularly every 28 days

Intervention Type DRUG

Other Intervention Names

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SMS995

Eligibility Criteria

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Inclusion Criteria

* Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut
* curative surgery impossible
* two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
* Age ≥ 18
* Karnofsky-index \> 60
* written informed consent
* proliferation index for Ki67

Exclusion Criteria

* hypersensitivity to octreotide
* poorly differentiated or small cell neuroendocrine tumors
* primary tumor outside of the midgut
* prior treatment with somatostatin-analogue \> 4 weeks
* prior treatment with alpha-interferon, chemotherapy, or chemoembolisation
* participation in any other clinical trial
* pregnancy or lactation
* no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years
* severe decompensated organ malfunction (heart-, liver- insufficiency)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No