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CompletedNCT00953394Updated Aug 6, 2009

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

A Phase 2 interventional study of continuous 5 fluouracil infusion plus long-acting octreotide in Neuroendocrine Tumors, sponsored by University of Turin, Italy. Completed at 7 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-06.

Sponsored by University of Turin, Italy · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Neuroendocrine Tumors

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Keywords

  • octreotide LAR
  • neuroendocrine carcinoma
  • metronomic 5fluorouracil
03

In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's enrollment of 29 is below the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

University of Turin, Italy is the lead sponsor of 206 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    treatment arm

    continuous 5 fluouracil infusion plus long-acting octreotide

    Drug: continuous 5 fluouracil infusion plus long-acting octreotide

Interventions

  • Drugcontinuous 5 fluouracil infusion plus long-acting octreotide

    long-acting octreotide acetate at a dose of 20 mg was administered intramuscularly every 4 weeks. 5fluorouracil was given as a protracted continuous infusion without interruption at a daily dose of 200 mg/m2 of body-surface area through an elastomeric pump connected to a central venous access.

    Also known as: metronomic 5 fluouracil infusion plus long-acting octreotide

06

What researchers measure

Primary outcomes

  1. disease free survival

    Time frame: 50 months

07

Study locations

7 sites
  • Federico Castiglione
    Alba, Cuneo 12051, Italy
  • Davide Perroni
    Saluzzo, Cuneo 12037, Italy
  • Benedetta Ferretti
    San Severino Marche, Macerata 62027, Italy
  • Sebastiano Bombaci
    Ivrea, Torino 10015, Italy
  • Anna Ferrero
    Orbassano, Torino 10043, Italy
  • Oscar Alabiso
    Novara, 28100, Italy
  • Enrica Milanesi
    Torino, 10126, Italy
08

References and documents

Publications

  • Brizzi 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. PubMed 19886987 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00953394
Lead sponsor
University of Turin, Italy
First posted
Aug 6, 2009
Start date
Feb 2002
Primary completion
Feb 2006
Completion
Dec 2006
Last update
Aug 6, 2009

Study contacts

Alfredo Berruti, PHD
study chair · Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Luigi Dogliotti, PHD
study director · Medical oncology, Department of Clinical and Biological Sciences, University of Turin
Libero Ciuffreda, MD
principal investigator · Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Torino

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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