Study to the Optimal Duration of Therapy With Oral Angiogenesis Inhibitors
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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
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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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.
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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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)

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 3610353 | c.vanherpen@onco.umcn.nl |
Netherlands | |
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 |
Responsible Party: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00777504 |
Other Study ID Numbers: |
UMCNONCO200801 |
First Posted: | October 22, 2008 Key Record Dates |
Last Update Posted: | September 16, 2011 |
Last Verified: | September 2011 |
angiogenesis inhibitor duration of therapy GIST |
Carcinoma, Renal Cell Gastrointestinal Stromal Tumors Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |