PATIENTS WITH LIVER COLORECTAL METASTASES NOT CANDIDATED TO SURGERY MedDRA version: 14.1 Level: LLT Classification code 10024700 Term: Liver metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ERBITUX*INFUS 1FL 50ML 5MG/ML
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923-56-4
Concentration unit: mg/ml milligram(s
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: COLORECTAL LIVER METASTASES UNRESECTABLE ACCORDING TO NORTLINGER CLASSIFCIATION (ANN.ONCOL.2009) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: EXTENSION OF DISEASE OUTSIDE THE LIVER
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: COMPLETE LIVER RESECTION AFTER CHEMOTHERAPY;Secondary Objective: TIME TO SURGERY TIME TO PROGRESSION TOLERABILITY RESPONSE RATE OVERALL SURVIVAL;Primary end point(s): COMPLETE RESECTION OF LIVER METASTASES;Timepoint(s) of evaluation of this end point: 4 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): TIME TO PROGRESSION;Timepoint(s) of evaluation of this end point: 24 MONTHS | — |
Countries
Italy
Contacts
Public ContactONCOLOGIA MEDICA A
ISTITUTO REGINA ELENA
Outcome results
None listed