NCT02403050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

4 years

First QC Date

March 16, 2015

Last Update Submit

March 25, 2015

Conditions

Esophageal Neoplasms

Keywords

Neoplasm StagingRadiotherapyFiducial Markers

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (8)

  • Patient survival

    6 months post radiotherapy

  • local recurrence of tumor

    6 months post radiotherapy

  • Patient survival

    12 months post radiotherapy

  • local recurrence of tumor

    12 months post radiotherapy

  • Patient survival

    18 months post radiotherapy

  • +3 more secondary outcomes

Study Arms (2)

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

Retrospective cohort

Images and clinical data from a retrospective group of patients without fiducial markers

Interventions

Fiducial markersDEVICE

2 fiducial markers (Visicoils) to be placed in the tumor area

Fiducial Markers Prospective cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or breast feeding.
  • Allergy to ciprofloxacin antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beatson Oncology Centre

Glasgow, G12 0YN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Fiducial Markers

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Reference StandardsWeights and MeasuresInvestigative TechniquesProstheses and ImplantsEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Vivienne MacLaren, MBChB, FRCP

    NHS Greater Glasgow & Clyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivienne MacLaren, MBChB, FRCP

CONTACT

441413017093v.maclaren@nhs.net

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 31, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

GB(1)