Esophageal Neoplasms
Conditions
Keywords
Neoplasm Staging, Radiotherapy, Fiducial Markers
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.
Interventions
DEVICEFiducial markers
2 fiducial markers (Visicoils) to be placed in the tumor area
Sponsors
NHS Greater Glasgow and Clyde
Study design
Observational model
CASE_CONTROL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Patient survival | 6 months post radiotherapy | — |
| local recurrence of tumor | 6 months post radiotherapy | radiological or clinical evidence of disease recurrence |
Countries
United Kingdom
Contacts
Primary ContactVivienne MacLaren, MBChB, FRCP
Outcome results
None listed