5FU and Octreotide Long-acting Release (LAR) for Neuroendocrine Tumors

What Was Tested

The trial (phase 2) is built around Octreotide.

Well differentiated neuroendocrine carcinomas have low proliferative activity and conventional chemotherapy is not recommended.

Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing metronomic chemotherapy in this clinical setting.

It had 1 arm (groups): treatment arm (experimental).

Continuous 5 fluouracil infusion plus long-acting octreotide.

The registry classes the interventions as drug.

More on the Plan

Primary Endpoint: the response to treatment, evaluated according to the RECIST criteria.

Who Took Part

29 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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;.

The full record lists 10 inclusion and 3 exclusion criteria; among the exclusions: 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;.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2002-02 with completion listed for 2006-02.

It ran at 7 sites in Italy (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: disease free survival (time frame: 50 months).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Octreotide in 29 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.