synchronous liver metastases in patients with the primary colorectal tumour in situ MedDRA version: 8.1 Level: LLT Classification code 10024700 Term: Liver metastases
Conditions
Interventions
Trade Name: Avastin
Product Name: bevacizumab
Pharmaceutical Form: Intravenous infusion
Other descriptive name: BEVACIZUMABUM
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Sponsors
The Netherlands Cancer Institute/ Antoni van Leeuwenhoek hospital
Radboud University Nijmegen Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histological proven primary colorectal cancer with synchronous liver metastases measurable liver metastases on CT scan (RECIST), postive signal of liver metastases on FDG-PET scan Age 18-80 WHO performance scale 0-1 ASA category I or II Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior systemic treatment for advanced disease prior treatment with anti-angiogenic drugs contra-indications for systemic therapy with bevacizumab concurrent severe or uncontrolled disease diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To obtain proof of principle that outgrowth of metastatic disease in colorectal cancer, as observed after resection of the primary tumour, can be influenced by pre-operative treatment ( before resection of the primary tumour) with the anti-angiogenic agent bevacizumab;Secondary Objective: surgical complication rate toxicity of medication;Primary end point(s): A relative change in the SUV ( Standardized Uptake Value) of the liver metastases on PET-CT scan after 9 weeks | — |
Countries
Netherlands
Outcome results
None listed