Adult patients (>18) who will receive standard neoadjuvant chemoradiation for primary oesophageal carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Histological confirmation of adenocarcinoma/squamous cell carcinoma of the oesophagus (2) Patients that will receive standard chemoradiation treatment before surgery for oesophageal carcinoma (3) Ability to give informed consent (4) Age 18 years or older (5) no prior therapy for oesophageal carcinoma
Exclusion criteria
Exclusion criteria: (1) pregnancy (2) Inflammation of the gastro-intestinal tract (3) Brain metastasis (4) Diastolic/ systolic Hypertension (>90/>140 mmHg), not responding to treatment (5) Arterial thromboembolism in medical history (6) Surgery within the month prior to start of bevacizumab treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameter is the alteration of the VEGF expression on mRNA level in the tumour before and during the course of neoadjuvant chemoradiation. In addition, in the bevacizumab treated cohort, the primary parameter is the activity (phosphorylation) of the VEGF receptor (VEGFR) in the tumour tissue obtained with biopsy and the microvessel density of the resection material of the tumour | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Determination of mRNA expression levels of other pro-angiogenic factors than VEGF and factors that may influence radiosensitivity in the tumour tissue. (2) Determination of protein expression of pro-angiogenic factors and factors that may influence radiosensitivity in the tumour tissue with IHC. (3) Determination of Epstein Barr virus (EBV) status in the tumour tissue. (4) Quantification of vascular parameters in the tumour tissue to assess on-going angiogenesis. (5) Measurement of the plasma concentration of pro-angiogenic factors to determine if this correlates with the expression levels in the tumour tissue. (6) Determination of the expression level of angioregulatory miRNAs in the tumour tissue to assess whether this is affected during neoadjuvant chemoradiation. | — |
Contacts
De Boelelaan 1117