PATIENTS WITH NEUROENDOCRINE TUMOR AND INOPERABLE LIVER METASTASIS MedDRA version: 14.1 Level: PT Classification code 10052399 Term: Neuroendocrine tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: na
Other descriptive name: na
Concentration unit: mg milligram(s)
Concentration type
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosis of gatroenteropancreatic (GEP), pulmonary or unknown primary NET 2.Unresectable liver metastases, according the judgment of surgeon, (the reasons for the opinion of surgeon should be made explicit) 3.Hepatic involvement =50% volume of the organ 4.Well (G1) or medium (G2) differentiated histology (according to WHO 2010 classification) 5.Ki67 = 20% (G1-G2) 6.Life expectancy > 6 months 7.Age = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Previous loco-regional postsurgical treatment 2. Low differentiated histology 3. Severe concomitant morbidities such as: severe coagulopathy (to be detailed), 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 4. Extrahepatic metastasis in critical locations as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions 5. Patients with progression disease only on the extra-hepatic localizations during screening phase 6. Patients with progression disease on critical location such as: brain, spinal cord, lung with respiratory impairment, symptomatic vertebral lesions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To verify if adding a locoregional treatment of liver metastasis (with trans-arterial embolization–TAE) to a medical treatment (with Octreotide LAR and eventually in combination with other medical treatments of proven efficacy), can prolong the progression free survival of patients affected by NET with inoperable liver metastases;Secondary Objective: -overall survival -objective response rate -quality of life -toxicity -prognostic factors;Primary end point(s): progression free survival;Timepoint(s) of evaluation of this end point: Radiological assessment will be perform, for both arms of study, at following times: -just before randomization (this assessment demonstrates liver progression of disease and contribute to define the eligibility of patient for randomization) -after 3 months (this assessment have to perform in both arms and, for experimental arm, contributes to orient the second round of TAE) -after 6 months from randomization and therefore, every 6 months (in boths arms of trial) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -overall survival -objective response rate;Timepoint(s) of evaluation of this end point: Radiological assessment will be perform, for both arms of study, at following times: -just before randomization (this assessment demonstrates liver progression of disease and contribute to define the eligibility of patient for randomization) -after 3 months (this assessment have to perform in both arms and, for experimental arm, contributes to orient the second round of TAE) -after 6 months from randomization and therefore, every 6 months (in boths arms of trial) | — |
Countries
Italy
Contacts
Public ContactUnita' Sperimentazione Clinica
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI DI NAPOLI
Outcome results
None listed