AUTOGEL Studie - phase III, randomised, double blind, stratified comparative, placebo controlled. Parallel groub, multicenter study to assess the effect of deep subcutaneous injections of lanreotide autogel 120 mg administered every 28 days on tumor progression free survival in patients with non functioning entero-pancreatic endocrine tumour
Laufzeit: 01.01.2007 - 31.12.2015
Kurzfassung
Einschlusskriterien:
- Male or female of 18 years of age or older
- entero-pancreatic endocrine tumour centrally confirmed
- metastatic disease and/or an locally advanced inoperable tumour
- tumour measurable according to RECIST criteria
- hormone related symptoms
- primary localisation in pancreas, mid-gut or hind gut
- moderately differentiates tumour
- proliferation index (Ki67) < 10%
- a>= grade 2 octreoscan assesses using the Krenning scale
- WHO performance score lower or equal to 2
Einschlusskriterien:
- Male or female of 18 years of age or older
- entero-pancreatic endocrine tumour centrally confirmed
- metastatic disease and/or an locally advanced inoperable tumour
- tumour measurable according to RECIST criteria
- hormone related symptoms
- primary localisation in pancreas, mid-gut or hind gut
- moderately differentiates tumour
- proliferation index (Ki67) < 10%
- a>= grade 2 octreoscan assesses using the Krenning scale
- WHO performance score lower or equal to 2
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