Angiogenic factor expression during fractionated irradiatio

Recruiting

• Conditions: Adult patients (>18) who will receive standard neoadjuvant chemoradiation for primary oesophageal carcinoma

• Registration Number: NL-OMON23950
• Lead Sponsor: VU University Medical Centre, Amsterdam, The Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary parameter is the alteration of the VEGF expression on mRNA level in the tumour before and during the<br>course of neoadjuvant chemoradiation. In addition, in the bevacizumab treated cohort, the primary parameter is the<br>activity (phosphorylation) of the VEGF receptor (VEGFR) in the tumour tissue obtained with biopsy and the microvessel<br>density of the resection material of the tumour

Secondary Outcome Measures

Name	Time	Method
(1) Determination of mRNA expression levels of other pro-angiogenic factors than VEGF and factors that may influence<br>radiosensitivity in the tumour tissue.<br>(2) Determination of protein expression of pro-angiogenic factors and factors that may influence radiosensitivity in the<br>tumour tissue with IHC.<br>(3) Determination of Epstein Barr virus (EBV) status in the tumour tissue.<br>(4) Quantification of vascular parameters in the tumour tissue to assess on-going angiogenesis.<br>(5) Measurement of the plasma concentration of pro-angiogenic factors to determine if this correlates with the<br>expression levels in the tumour tissue.<br>(6) Determination of the expression level of angioregulatory miRNAs in the tumour tissue to assess whether this is<br>affected during neoadjuvant chemoradiation.