Fluorescence Molecular Endoscopy of locally advanced esophageal carcinoma using bevacizumab-800CW to evaluate dose response after neoadjuvant chemoradiotherapy: a single-center feasibility study.

Completed

Conditions: esophageal cancer
locally advanced esophageal cancer
10017990
10017991

Registration Number: NL-OMON48982

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

- Locally advanced esophageal carcinoma (cT1b-4a N0-3 M0) in multi-disciplinary
esophageal oncology meeting agreed on long course neoadjuvant
chemoradiotherapy, followed by esophagectomy;
- Age >= 18 years;
- Written informed consent.

Exclusion Criteria

- Patients with psychological diseases or medical issues who are not able to
sign informed consent form;
• Concurrent uncontrolled medical conditions;
• Pregnancy or breast feeding. A negative pregnancy test must be available for
women of childbearing potential (i.e. premenopausal women with intact
reproductive organs and women less than two years after menopause);
• Irradical endoscopic mucosal resection (EMR) or endoscopic submucosal
dissection (ESD) of primary tumor prior to start of neoadjuvant
chemoradiotherapy
• Received a different investigational drug within 30 days prior to the dose of
bevacizumab-800CW;
• History of infusion reactions to bevacizumab or other monoclonal antibodies;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of this study include<br /><br>• Discrimination of tumorous and non-tumorous tissue based on in vivo and ex<br /><br>vivo fluorescence measurements from bevacizumab-800CW gained during<br /><br>fluorescence endoscopy procedures;<br /><br>• The safety of bevacizumab-800CW through monitoring vital signs, the injection<br /><br>site and evaluating possible (severe) adverse events (SAE/AEs).</p><br>

Secondary Outcome Measures