Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00777504|
Recruitment Status : Unknown
Verified September 2011 by Radboud University.
Recruitment status was: Recruiting
First Posted : October 22, 2008
Last Update Posted : September 16, 2011
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Gastrointestinal Stromal Tumor||Drug: usage oral angiogenesis inhibitor Drug: stop oral angiogenesis inhibitor||Phase 4|
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 diameter of the lesions, or occurence of new lesions. However, angiogenesis inhibitors have a rather cytostatic than cytotoxic effect compared to chemotherapeutics, as a result of which less frequently reduction of tumor volume is being seen.
Often in the centre of the lesion necrosis is shown. Sometimes accompanied with edema; so even tumor volume increase can be the result without real progression being the case. Recently, in our clinic, we found a number of patients, treated with oral angiogenesis inhibitors, a remarkable quickening of progressive disease and complaints after stopping this treatment. Reintroduction of the same or another type of angiogenesis inhibitor subsequently lead to a new stabilization. The causality of this phenomenon is unknown. Perhaps that the inhibitory effect of the angiogenesis is not fully exhausted at the moment that progressive disease on CT is observed. An alternative explanation is contra reaction of longterm angiogenetic inhibition through upregulation of proangiogenic factors with subsequent vascular expansion and edema. This study means to gain more insight information about the optimal treatment policy when progressive disease is found in patients treated with oral angiogenesis inhibitors. Because of the increase of patients that is being treated with these products, both in trials as in daily clinical practice, this is important to investigate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||April 2012|
Active Comparator: A
When PD is being determined the patient will continue with the oral angiogenesis inhibitors for 2 more weeks. After 2 weeks, an Avastinscan will be made and/or a dynamic contrast enhanced MRI (DCE-MRI). After evaluating these scans patients in group A now stop the orale angiogenesis inhibitor.
Drug: usage oral angiogenesis inhibitor
see under 'study arms'
Active Comparator: B
When PD is being determined the patient will continue with the oral angiogenesis inhibitors for 2 more weeks. After 2 weeks, an Avastinscan will be made and/or a dynamic contrast enhanced MRI (DCE-MRI). After evaluating these scans patients in group B continue with angiogenesis inhibitors for 2 more weeks. After these 2 weeks(so 4 weeks after inclusion) another Avastinscan will be made and/or a dynamic contrast enhanced MRI (DCE-MRI) and a FDG-PET-scan.
Drug: stop oral angiogenesis inhibitor
see under 'study arms'
- Signs of progressive disease on CT-scan, DCE-MRI or Avastin scan [ Time Frame: 4 weeks ]
- Effect on Quality of life as record by questionaires [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777504
|Contact: C.M.L. van Herpen, Md, Phd||31 24 firstname.lastname@example.org|
|University Medical Center Nijmegen st Radboud||Recruiting|
|Nijmegen, Gelderland, Netherlands, 6525 GH|
|Principal Investigator: C.M.L van Herpen, Md, Phd|
|Principal Investigator:||C.M.L. van Herpen, MD, Phd||UMCN st Radboud|