kidney cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •locally advanced irresectable or metastatic renal cell cancer •no untreated brain metastases (CT or MRI not necessary in the absence of symptoms) •no uncontrolled hypertension •no clinically significant cardiovascular events or disease during the last 12 months •no surgery in the last 4 weeks •no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months •no treatment with a tyrosine kinase inhibitor during the last 4 weeks •measurable disease with x-ray or CT scan, at least one site of disease must be unidimensionally measurable as follows: X ray >= 20 mm Spiral CT scan >= 10 mm Non-spiral CT scan >= 20 mm •>= 18 years •clear cell histology component •absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial •before patient randomization, written informed consent must be given according to GCP, and local regulations
Exclusion criteria
Exclusion criteria: Are formulated as "no existence of" in inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in SUVmax between baseline 89Zr-bevacizumab PET scan and the scan performed after 2 and 6 weeks of treatment with sunitinib or bevacizumab plus interferon in patients with RCC. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, after 3 months of treatment. | — |
Countries
Netherlands
Outcome results
None listed