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| Name | Class |
|---|---|
| Noordwest Ziekenhuisgroep | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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The main question of this study is if and when VEGF (vascular endothelial growth factor) expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits subsequent vessel growth in the tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| on-treatment tumor biopsie | No Intervention | patients will undergo an pre-treatment and on-treatment tumor biopsy, to measure VEGF expression, and identify the time point of induction of VEGF expression. | |
| bevacizumab | Experimental | These patients will receive bevacizumab once a week during their chemoradiation, starting at the identified time point of enhanced VEGF expression. These patients will also undergo and pre-treatment tumor biopsy and 1 tumor biopsy 1 week after the start of bevacizumab treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | patients will receive bevacizumab (3mg/kg/wk) starting from the identified induction time point of VEGF expression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of VEGF mRNA expression in tumor biopsies | To compare the VEGF mRNA expression in the pre-treatment and on-treatment tumor biopsies, to measure the change in VEGF expression from baseline. | 5 weeks |
| Change of VEGFR2 phosphorylation with IHC | To determine the level of pVEGFR2 expression in tumor biopsies of patients that received bevacizumab, and to compare that to their pre-treatment expression levels, to identify the changes in expression from baseline. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of mRNA expression of other pro-angiogenic factors | To identify the expression of other pro-angiogenic factors in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies). | 5 weeks |
| Changes in protein expression of pro-angiogenic factors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henk Verheul, MD/ PhD | Contact | h.verheul@vumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU university medical center | Recruiting | Amsterdam | North Holland | 1081 HV | Netherlands |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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To identify the protein expression of other pro-angiogenic factors in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies). |
| 5 weeks |
| Changes in vascular parameters in the tumor tissue to asses ongoing angiogenesis | To identify the expression of CD31+ and pericyte markers with IHC staining in the tumor, and to measure the changes from baseline expression (pre-treatment vs on-treatment biopsies). | 5 weeks |
| Noordwest Ziekenhuisgroep | Recruiting | Alkmaar | Netherlands |
|
| Academisch Medisch Centrum | Recruiting | Amsterdam | Netherlands |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |