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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiducial Markers Prospective cohort | 2 fiducial markers (Visicoils) to be placed in the tumor area at the routine endoscopic ultrasound (EUS) appointment. |
| |
| Retrospective cohort | Images and clinical data from a retrospective group of patients without fiducial markers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiducial markers | Device | 2 fiducial markers (Visicoils) to be placed in the tumor area |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vivienne MacLaren, MBChB, FRCP | Contact | 441413017093 | v.maclaren@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Vivienne MacLaren, MBChB, FRCP | NHS Greater Glasgow & Clyde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beatson Oncology Centre | Recruiting | Glasgow | G12 0YN | United Kingdom |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D057918 | Fiducial Markers |
| ID | Term |
|---|---|
| D012015 | Reference Standards |
| D014894 | Weights and Measures |
| D008919 | Investigative Techniques |
| D019736 | Prostheses and Implants |
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| 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 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |