Efficacy and Safety of High Dose Regimen of Octreotide LAR in Patients With Neuroendocrine Tumors in Progressive Disease: A Phase II, Open, Multicentric Prospective Study
The patient population will include the patients with a histologically documented diagnosis
of WDNET, defined according to the last WHO Classification criteria for NET of
gastro-entero-pancreatic, bronchial, thymic or other origin; and showing tumor progression
under a standard dose treatment with LAR (30 mg every 28 days) for at least 6 months.
Progressive disease will be defined as increased tumor size according to RECIST definitions.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Annamaria Colao, MD, PhD
University Federico II of Naples
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health