Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT 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.
Study:
NCT00953394
Study Brief:
Protocol Section:
NCT00953394