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Angiogenic factor expression during fractionated irradiation

Pilot study to determine the effect of fractionated radiotherapy on expression of pro-angiogenic factors in oeshophagus carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23950
Enrollment
40
Registered
2014-02-18
Start date
2014-02-20
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Patients will undergo 1 extra endoscopic biopsy to collect tumour tissue. In addition, on four time points blood samples will be collected. The time point of this biopsy and blood collection depends o

Sponsors

VU University Medical Centre, Amsterdam, The Netherlands
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactH.M.W. Verheul

De Boelelaan 1117

h.verheul@vumc.nl+31 (0)20 4444321/300

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)