Status:
UNKNOWN
Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
Lead Sponsor:
Radboud University Medical Center
Conditions:
Renal Cell Carcinoma
Gastrointestinal Stromal Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if and how often an unexpected fast increase of disease and complaints shows after stopping the anti-angiogenetic therapy
Detailed Description
Until now, in trials it is common to stop therapy when progressive disease occurs; RECIST criteria are used, in which progressive disease is defined as \>20% increase of the sum of the longest diamete...
Eligibility Criteria
Inclusion
- metastatic or advanced solid cancer that is treated with an oral angiogenesis inhibitor, with clinical indication to stop this therapy based on progressive disease as defined by the RECIST criteria on the CT scan. It needs a minimum of 1 previous evaluation of stable disease and the patient must have been treated with angiogenesis inhibitors for at least 12 weeks.
- age ≥18 years
- given informed consent
Exclusion
- pregnant or lactating
- metastatic sites solely in bone or liver
- contraindication for CT or Avastin scan (claustrophobia, severe renal function disorder, allergy for contrast fluids, allergy for Avastin)
- insufficient condition to continue treatment with angiogenesis inhibitors.
- contraindication for dynamic contrast MRI (deteriorated renal functions with clearance \<60ml/min, metal in body, claustrophobia, pacemaker, defibrillator)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00777504
Start Date
October 1 2008
End Date
April 1 2012
Last Update
September 16 2011
Active Locations (1)
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1
University Medical Center Nijmegen st Radboud
Nijmegen, Gelderland, Netherlands, 6525 GH