Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
85
30 mg intramuscularly every 28 days
Sodium chloride intramuscularly every 28 days
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Halle, Germany
Novartis Investigative Site
Hamburg, Germany
Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.
Time frame: Up to 7 years
Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
Time frame: at 3 month intervals
Biochemical Response at 3 Month Intervals
Time frame: at 3 month intervals up to 18 moths
Symptom Control at 3 Month Intervals
Time frame: at 3 month intervals up to 18 moths
Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study
Time frame: at three-month intervals
Survival
Time frame: at least on a monthly basis
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Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
München, Germany