Clinical trial NCT02403050: Feasibility Study of Fiducial Markers in Oesophageal Cancer
Official title: Feasibility Study to Assess the Benefit of Using Fiducial Markers for Patients Receiving Radiotherapy for Cancer of the Oesophagus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Neoplasms
Keywords: Neoplasm Staging
Radiotherapy
Fiducial Markers
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation
timeFrame: baseline (pre-radiotherapy)
Secondary outcomes:
measure: Patient survival
timeFrame: 6 months post radiotherapy
measure: local recurrence of tumor
timeFrame: 6 months post radiotherapy
measure: Patient survival
timeFrame: 12 months post radiotherapy
measure: local recurrence of tumor
timeFrame: 12 months post radiotherapy
measure: Patient survival
timeFrame: 18 months post radiotherapy
measure: local recurrence of tumor
timeFrame: 18 months post radiotherapy
measure: Patient survival
timeFrame: 2 years post radiotherapy
measure: local recurrence of tumor
timeFrame: 2 years post radiotherapy
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Beatson Oncology Centre
Study officials:
affiliation: NHS Greater Glasgow & Clyde
name: Vivienne MacLaren, MBChB, FRCP
role: PRINCIPAL_INVESTIGATOR
References: