Feasibility Study of Fiducial Markers in Oesophageal Cancer

NHS Trust

Status

Unknown

Conditions

Esophageal Neoplasms

Treatments

Device: Fiducial markers

Study type

Observational

Funder types

Other

Identifiers

NCT02403050

GN14ON144

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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