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Spots Global Cancer Trial Database for 5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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