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Randomized Phase 3 Trial Evaluating the Efficacy of Locoregional Treatment With Transarterial Embolization (TAE) for Liver Metastases, in Combination With Octreotide LAR, in Patients With Neuroendocrine Tumor and Inoperable Liver Metastasis.


Phase 3
18 Years
80 Years
Not Enrolling
Both
Neuroendocrine Tumors

Thank you

Trial Information

Randomized Phase 3 Trial Evaluating the Efficacy of Locoregional Treatment With Transarterial Embolization (TAE) for Liver Metastases, in Combination With Octreotide LAR, in Patients With Neuroendocrine Tumor and Inoperable Liver Metastasis.


NET patients with unresectable hepatic metastases at diagnosis or who have not received any
antineoplastic therapy for metastatic disease will be registered in the study and sent to a
screening phase. Randomization will be proposed to patients with progressive hepatic or
symptomatic disease.


Inclusion Criteria:



At registration

- Diagnosis of NET of gastroenteropancreatic (GEP), pulmonary or unknown primary site
origin

- Unresectable liver metastases, according the judgment of surgeon, (the reasons for
the opinion of surgeon should be made explicit)

- Hepatic involvement ≤50% volume of the organ

- Well (G1) or medium (G2) differentiated histology (according to WHO 2010
classification)

- Ki67 ≤ 20% (G1-G2)

- Life expectancy > 6 months

- Age ≥ 18 and < 80 years

At randomization

- Confirmed criteria as per registration

- Radiological progression of hepatic localizations, verified during screening phase,
or presence of symptoms requiring an immediate treatment with somatostatin analogues
(I.E. in case of a functioning tumour, that doesn't need of a symptomatic therapy
with analogues of somatostatin [insulinoma, gastrinoma, ACTHoma], it is necessary to
wait for radiological progression)

Exclusion Criteria:

At registration

- Previous loco-regional postsurgical treatment

- Low differentiated histology

- Severe concomitant morbidities such as: severe coagulopathy, severe liver failure (to
be detailed), renal failure (creatinine > 2.0 mg/dl) and heart failure (NYHA 3-4 or
instable ischemic heart disease), contraindicating the interventional procedure or
influencing the general prognosis (Investigator to provide details of exclusion)

- Extrahepatic metastasis in critical locations as: brain, spinal cord, lung with
respiratory impairment, symptomatic vertebral lesions

At randomization

- Patients with progression of disease only on the extra-hepatic localizations during
screening phase

- Patients with progression disease on critical location such as: brain, spinal cord,
lung with respiratory impairment, symptomatic vertebral lesions

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

A Colao, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Federico II University

Authority:

Italy: Ethics Committee

Study ID:

LOTUS

NCT ID:

NCT01755182

Start Date:

January 2013

Completion Date:

December 2017

Related Keywords:

  • Neuroendocrine Tumors
  • locoregional treatment
  • liver metastases
  • transarterial embolization
  • upfront treatment
  • inoperable
  • octreotide
  • gastroenteropancreatic (GEP)primary
  • pulmonary primary
  • primary unknown origin
  • systemic therapy
  • Neoplasm Metastasis
  • Neuroendocrine Tumors
  • Liver Neoplasms

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