Feasibility Study of Fiducial Markers in Oesophageal Cancer

March 25, 2015 updated by: NHS Greater Glasgow and Clyde

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Recruiting
        • Beatson Oncology Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A retrospective group of patients images without markers, will be compared to a prospective group of patients who will be imaged and treated following implantation of fiducial tumor markers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation
Time Frame: 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.
baseline (pre-radiotherapy)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Investigators

  • Principal Investigator: Vivienne MacLaren, MBChB, FRCP, NHS Greater Glasgow & Clyde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN14ON144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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