Studie naar de optimale therapieduur van orale angiogenese remmers

• Conditions: Patients with a metastatic malignancy, treated with a registered oral angiogenetic inhibitor (tyrosine kinase inhibitor), who have progressive disease according to RECIST on CT-evaluation

• Registration Number: EUCTR2008-002672-95-NL
• Lead Sponsor: niversity Medical Centre Nijmegen St Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-metastastic 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
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

-pregnant or lactating
-metastatic sites solely in bone or liver
-contra-indication for CT or Avastinscan (claustrofobia, severe renal function disorder, allergy for contrastfluids, allergy for Avastin)
-insufficient condition to continue treatment with angiogenesis inhibitors.
-contra-indication for dynamic contrast MRI (deteriorated renal functions with clearance <60ml/min, metal in body, claustrofobia, pacemaker, defibrilator)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To determine if and how often an unexpected fast increase of disease and complaints shows after stopping the anti-angiogenetic therapy<br>;Secondary Objective: 2. To predict which patients are at risk for this phenomenom.<br>3. Record the influence of stopping angiogenesis inhibotors on the quality of life;Primary end point(s): To determine if and how often an unexpected fast increase of disease and complaints shows after stopping the anti-angiogenetic therapy<br>To predict which patients are at risk for this phenomenom.<br>Record the influence of stopping angiogenesis inhibotors on the quality of life