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Brief Title: 5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors
Official Title: Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.
Study ID: NCT00953394
Brief Summary: Well differentiated neuroendocrine carcinomas have low proliferative activity and conventional chemotherapy is not recommended. Metronomic chemotherapy, i.e. the frequent administration of cytotoxic drugs at low doses, has demonstrated antiangiogenetic properties. Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing metronomic chemotherapy in this clinical setting. A phase II study was designed to test the activity of protracted 5-fluorouracil (5FU) infusion plus long-acting release (LAR) octreotide for patients with neuroendocrine carcinoma.
Detailed Description: Metastatic or locally advanced well differentiated neuroendocrine carcinoma were treated with 5Fluorouracil protracted intravenous infusion (200 mg/m2 daily) plus Octreotide LAR (20 mg monthly). Primary Endpoint: the response to treatment, evaluated according to the RECIST criteria. Secondary Endpoints: * 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Federico Castiglione, Alba, Cuneo, Italy
Davide Perroni, Saluzzo, Cuneo, Italy
Benedetta Ferretti, San Severino Marche, Macerata, Italy
Sebastiano Bombaci, Ivrea, Torino, Italy
Anna Ferrero, Orbassano, Torino, Italy
Oscar Alabiso, Novara, , Italy
Enrica Milanesi, Torino, , Italy
Name: Alfredo Berruti, PHD
Affiliation: Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Role: STUDY_CHAIR
Name: Luigi Dogliotti, PHD
Affiliation: Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Role: STUDY_DIRECTOR
Name: Libero Ciuffreda, MD
Affiliation: Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino
Role: PRINCIPAL_INVESTIGATOR