Feasibility Study of Fiducial Markers in Oesophageal Cancer

Study Overview
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Brief Summary
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Currently, patients of suitable fitness with non-metastatic esophageal cancer are treated with surgery, radiotherapy or chemoradiotherapy. If treated with radio or chemoradiotherapy, a Computerised tomography (CT) scan is performed and is the dataset used for planning radiotherapy. Information from the endoscopic ultrasound (EUS), performed during routine staging, is used to help localize the tumor, as tumors of the esophagus are poorly visualised on CT. This information is subjective and dependant on the clinician performing the procedure. The tumor is described in relation to common anatomical landmarks. Interpretion of this information can lead to over-compensation when attempting to cover the tumor with a radiation field, to avoid a miss. It is thought that using fiducial markers called Visicoils placed in or adjacent to the tumor's top and bottom extent at the time of EUS, will lead to better definition of the tumor in the planning process and hence, improvement in local tumor control, and reduction in radiotherapy dose to normal tissue.

Official Title
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Feasibility Study to Assess the Benefit of Using Fiducial Markers for Patients Receiving Radiotherapy for Cancer of the Oesophagus

Conditions
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Esophageal Neoplasms

Intervention / Treatment
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* Device: Fiducial markers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: esophageal adenocarcinoma or squamous carcinoma, or undifferentiated carcinoma. No previous radiotherapy or chemotherapy. Fit for radical treatment of their cancer with reasonable lung function, Fev1 >40%, and EUS planned. ECOG Performance Status 0-1: 0 - Fully active, able to carry on all predisease performance without restriction 1 - Restricted in physically strenuous activity Exclusion Criteria: Pregnancy or breast feeding. Allergy to ciprofloxacin antibiotics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fiducial Markers Prospective cohort<br>2 fiducial markers (Visicoils) to be placed in the tumor area at the routine endoscopic ultrasound (EUS) appointment. | Device: Fiducial markers<br>* 2 fiducial markers (Visicoils) to be placed in the tumor area<br>|
| Retrospective cohort<br>Images and clinical data from a retrospective group of patients without fiducial markers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation | Comparison of intra- and inter-observer variability in estimation of tumor target volume (mean and standard deviation) in the prospective (fiducial markers) and retrospective (no fiducial markers) cohorts. Data will be reported using planning volumes measured in cubic centimetres. | baseline (pre-radiotherapy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival |  | 6 months post radiotherapy | 
| local recurrence of tumor | radiological or clinical evidence of disease recurrence | 6 months post radiotherapy | 
| Patient survival |  | 12 months post radiotherapy | 
| local recurrence of tumor | radiological or clinical evidence of disease recurrence | 12 months post radiotherapy | 
| Patient survival |  | 18 months post radiotherapy | 
| local recurrence of tumor | radiological or clinical evidence of disease recurrence | 18 months post radiotherapy | 
| Patient survival |  | 2 years post radiotherapy | 
| local recurrence of tumor | radiological or clinical evidence of disease recurrence | 2 years post radiotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasm Staging, Radiotherapy, Fiducial Markers