To study the effect of daily irradiation on the growth of blood vessels in cancer of the gullet

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002563-25-NL

Enrollment

Registered

2013-09-19

Start date

2014-01-13

Completion date

Unknown

Last updated

2018-03-12

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

Conditions

Angiogenesis in esophageal cancer MedDRA version: 20.0 Level: LLT Classification code 10015362 Term: Esophageal cancer System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10030151 Term: Oesophageal cancer System Organ Class: 100000004864

Interventions

Trade Name: Avastin Pharmaceutical Form: Infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients that will receive standard chemoradiation treatment before surgery for oesophageal adenocarcinoma (2) Ability to give informed consent (3) Age 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: (1) Evidence of bleeding diathesis, coagulopathy, prolonged INR or PTT (2) Pregnancy (3) Inflammation of the gastro-intestinal tract (4) Brain metastasis (5) Diastolic/ systolic Hypertension (>90/>140 mmHg), not responding to treatment (6) Arterial thromboembolism in medical history (7) Surgery within the month prior to start of bevacizumab treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: First primary objective: To determine the time point of induction of VEGF expression in the tumour tissue of oesophagus carcinomas during chemoradiation. Second primary objective: To determine whether the tumour promoting effects of this induction of VEGF expression can be inhibited by administration of bevacizumab.;Secondary Objective: (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. (7) Immune cell profiling by flow cytometric analysis (FACS) ;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 1st timepoint: after study biopsy of the tumour during the chemoradiation treatment. 2nd timepoint: after the surgical resection of the residual tumour.	—

Measure

Time frame

Main Objective: First primary objective: To determine the time point of induction of VEGF expression in the tumour tissue of oesophagus carcinomas during chemoradiation. Second primary objective: To determine whether the tumour promoting effects of this induction of VEGF expression can be inhibited by administration of bevacizumab.;Secondary Objective: (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. (7) Immune cell profiling by flow cytometric analysis (FACS) ;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 1st timepoint: after study biopsy of the tumour during the chemoradiation treatment. 2nd timepoint: after the surgical resection of the residual tumour.

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Secondary

Measure	Time frame
Secondary end point(s): (1) mRNA expression levels of other pro-angiogenic factors than VEGF and factors that may influence radiosensitivity in the tumour tissue. (2) Protein expression of pro-angiogenic factors and factors that may influence radiosensitivity in the tumour tissue with IHC. (3) Epstein Barr virus (EBV) status in the tumour tissue. (4) Quantification of vascular parameters in the tumour tissue to assess on-going angiogenesis. (5) Plasma concentration of pro-angiogenic factors (6) Expression level of angioregulatory miRNAs in the tumour tissue (7) Immune cell profiling by flow cytometric analysis (FACS) ;Timepoint(s) of evaluation of this end point: 1st timepoint: after study biopsy of the tumour during the chemoradiation treatment. 2nd timepoint: after the surgical resection of the residual tumour.	—

Measure

Time frame

Secondary end point(s): (1) mRNA expression levels of other pro-angiogenic factors than VEGF and factors that may influence radiosensitivity in the tumour tissue. (2) Protein expression of pro-angiogenic factors and factors that may influence radiosensitivity in the tumour tissue with IHC. (3) Epstein Barr virus (EBV) status in the tumour tissue. (4) Quantification of vascular parameters in the tumour tissue to assess on-going angiogenesis. (5) Plasma concentration of pro-angiogenic factors (6) Expression level of angioregulatory miRNAs in the tumour tissue (7) Immune cell profiling by flow cytometric analysis (FACS) ;Timepoint(s) of evaluation of this end point: 1st timepoint: after study biopsy of the tumour during the chemoradiation treatment. 2nd timepoint: after the surgical resection of the residual tumour.

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Countries

Netherlands

Contacts

Public ContactSecretariaat Medische Oncologie

VU University Medical Centre

+310204444321

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026