Feasibility Study of Fiducial Markers in Oesophageal Cancer

• Conditions: Esophageal Neoplasms
• Interventions: Device: Fiducial markers

• Registration Number: NCT02403050
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-03
• Study Start: 2015-03
• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-25
• Last Update Submitted: 2015-03-25
• Study First Posted: 2015-03-31
• Last Update Posted: 2015-03-31
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fiducial Markers Prospective cohort	Fiducial markers	2 fiducial markers (Visicoils) to be placed in the tumor area at the routine endoscopic ultrasound (EUS) appointment.

Primary Outcome Measures

Name	Time	Method
Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation	baseline (pre-radiotherapy)	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.

Secondary Outcome Measures

Name	Time	Method
Patient survival	2 years post radiotherapy
local recurrence of tumor	2 years post radiotherapy	radiological or clinical evidence of disease recurrence

Trial Locations

Locations (1)

Beatson Oncology Centre; 🇬🇧 Glasgow, United Kingdom