Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 21, 2008
CompletedFirst Posted
Study publicly available on registry
October 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedSeptember 16, 2011
September 1, 2011
3.3 years
October 21, 2008
September 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Signs of progressive disease on CT-scan, DCE-MRI or Avastin scan
4 weeks
Secondary Outcomes (1)
Effect on Quality of life as record by questionaires
4 weeks
Study Arms (2)
A
ACTIVE COMPARATORWhen 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.
B
ACTIVE COMPARATORWhen 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Nijmegen st Radboud
Nijmegen, Gelderland, 6525 GH, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
C.M.L. van Herpen, MD, Phd
UMCN st Radboud
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2008
First Posted
October 22, 2008
Study Start
October 1, 2008
Primary Completion
January 1, 2012
Study Completion
April 1, 2012
Last Updated
September 16, 2011
Record last verified: 2011-09