Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.
Metastatic or locally advanced well differentiated neuroendocrine carcinoma were treated
with 5Fluorouracil protracted intravenous infusion (200 mg/m2 daily) plus Octreotide LAR (20
Primary Endpoint: the response to treatment, evaluated according to the RECIST criteria.
- toxicity, graded according to the NCI-CTG criteria;
- symptomatic response: evaluated according to the changes in both the frequency and
intensity of symptoms;
- biochemical response: evaluated considering the changes in the tumor marker levels
(circulating Chromogranin A);
- time to progression and survival: were measured from the date of treatment start to the
date of progression and the date of last follow-up or death, respectively.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
disease free survival
Alfredo Berruti, PHD
Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Italy: The Italian Medicines Agency