Clinical trial · Interventional
5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors
Continuous 5-fluorouracil Infusion Plus Long Acting Octreotide in Advanced Well Differentiated Neuroendocrine Carcinomas. A Phase II Trial of the Piemonte Oncology Network.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| continuous 5 fluouracil infusion plus long-acting octreotide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- description
- continuous 5 fluouracil infusion plus long-acting octreotide
- interventionNames
- Drug: continuous 5 fluouracil infusion plus long-acting octreotide
Primary outcomes (1)
- measure
- disease free survival
- timeFrame
- 50 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histological diagnosis of well-differentiated neuroendocrine carcinoma according to the World Health Organization (WHO) classification; * locally advanced or metastatic disease not amenable to surgery with radical intent; * at least one measurable target lesion; * radiological documentation of progressive disease; * ECOG performance status grade \<=2; * life expectancy \>12 weeks; * adequate bone marrow reserve; * adequate hepatic and renal function; * ability to comply with the protocol procedures (including geographic accessibility); * written informed consent. Exclusion Criteria: * non-malignant systemic disease or conditions that precluded patients from receiving the study therapy; * second primary malignancies and previous systemic antineoplastic treatment including somatostatin analogues; * history of prior malignancy, excepted for cured non-melanoma skin cancer, and cured in situ cervical carcinoma.
References
Publications (1)
- DERIVEDBrizzi MP, Berruti A, Ferrero A, Milanesi E, Volante M, Castiglione F, Birocco N, Bombaci S, Perroni D, Ferretti B, Alabiso O, Ciuffreda L, Bertetto O, Papotti M, Dogliotti L. Continuous 5-fluorouracil infusion plus long acting octreotide in advanced well-differentiated neuroendocrine carcinomas. A phase II trial of the Piemonte oncology network. BMC Cancer. 2009 Nov 3;9:388. doi: 10.1186/1471-2407-9-388. PMID 19886987