Esophageal NeoplasmsNCT02403050
Feasibility Study of Fiducial Markers in Oesophageal Cancer
An observational study of Esophageal Neoplasms, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Fiducial markers
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnancy or breast feeding.
- Allergy to ciprofloxacin antibiotics
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Beatson Oncology Centre
Glasgow, G12 0YN
Vivienne MacLaren, MBChB, MRCP, 441413017093, v.maclaren@nhs.net
About this study
Official title: Feasibility Study to Assess the Benefit of Using Fiducial Markers for Patients Receiving Radiotherapy for Cancer of the Oesophagus
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.
- Conditions
- Esophageal Neoplasms
- Being tested
- Fiducial markers
- Keywords
- Neoplasm Staging, Radiotherapy, Fiducial Markers
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiducial markersDevice
2 fiducial markers (Visicoils) to be placed in the tumor area
| Study group | Role | What they receive |
|---|---|---|
| Fiducial Markers Prospective cohort | 2 fiducial markers (Visicoils) to be placed in the tumor area at the routine endoscopic ultrasound (EUS) appointment. Receives: Device: Fiducial markers | |
| Retrospective cohort | Images and clinical data from a retrospective group of patients without fiducial markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (pre-radiotherapy)
Secondary outcomes (8)
Patient survival
Measured: 6 months post radiotherapy
local recurrence of tumor
radiological or clinical evidence of disease recurrence
Measured: 6 months post radiotherapy
Patient survival
Measured: 12 months post radiotherapy
local recurrence of tumor
radiological or clinical evidence of disease recurrence
Measured: 12 months post radiotherapy
Patient survival
Measured: 18 months post radiotherapy
local recurrence of tumor
radiological or clinical evidence of disease recurrence
Measured: 18 months post radiotherapy
Patient survival
Measured: 2 years post radiotherapy
local recurrence of tumor
radiological or clinical evidence of disease recurrence
Measured: 2 years post radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivienne MacLaren, MBChB, FRCP, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403050
- Sponsor's protocol ID
- GN14ON144
- Status last verified
- Mar 2015
- First submitted
- 16 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Assess the Benefit of Using Fiducial Markers for Patients Receiving Radiotherapy for Cancer of the Oesophagus
- ClinicalTrials.gov ID
- NCT02403050
- Acronym / sponsor ID
- GN14ON144
- Conditions
- Esophageal Neoplasms
- Keywords
- Neoplasm Staging, Radiotherapy, Fiducial Markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiducial Markers Prospective cohort | – | Device: Fiducial markers2 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy or breast feeding.
- Allergy to ciprofloxacin antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fiducial markers2 fiducial markers (Visicoils) to be placed in the tumor area | Device | Fiducial Markers Prospective cohort |
Primary outcome
Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation
Time frame: 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.
8 secondary outcomes
Patient survival
Time frame: 6 months post radiotherapy
local recurrence of tumor
Time frame: 6 months post radiotherapy
Patient survival
Time frame: 12 months post radiotherapy
local recurrence of tumor
Time frame: 12 months post radiotherapy
Patient survival
Time frame: 18 months post radiotherapy
local recurrence of tumor
Time frame: 18 months post radiotherapy
Patient survival
Time frame: 2 years post radiotherapy
local recurrence of tumor
Time frame: 2 years post radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivienne MacLaren, MBChB, FRCP principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasms, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vivienne MacLaren, MBChB, FRCP (441413017093, v.maclaren@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra- and inter-observer variability of tumor target volume (cubic centimetres) estimation (time frame: baseline (pre-radiotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.