Esophageal NeoplasmFIDECHONCT03057288
Prospective Study Evaluating the Feasibility of Fiducial Markers Placement for Patients With Esophageal or Rectal Cancer
A study testing fiducial markers placement in people with Esophageal Neoplasm and Rectal Neoplasms, run by Société Française d'Endoscopie Digestive at 1 site in France.
Trial summary
It is a multicenter prospective observational study including consecutive patients with esophageal tumor or rectum with indication for radiotherapy The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasm, Rectal Neoplasms
- What is being tested?
- fiducial markers placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2017to 2 Sep 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patients > 18 years
- Patients presenting an oesophageal or a rectal tumor passable with a linear echoendoscope
- TP> 60% et Platelets > 50 000/mm3
- No anticoagulant treatment or antiagregants being taken other than aspirin in the five days preceding the EUS
- Patient affiliated to a social security scheme (payee or beneficiary)
- Patient who signed a free and informed consent
Who cannot join
- Patient < 18 years
- Pregnant Woman
- Tumor stenosis impassable by the linear echoendoscope
- Patient participation refusal
- Patient under legal protection regime (guardianship / curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Evaluating the Feasibility of Fiducial Markers Placement Under Echoendoscopy (EUS) Guidance for Patients With Esophageal or Rectal Cancer With an Indication of Radiotherapy
It is a multicenter prospective observational study including consecutive patients with esophageal tumor or rectum with indication for radiotherapy
The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance. The evaluation criteria are:
- Success rate evaluation of the placement of two markers : one in the upper part of the tumor and one in the lower part. Success of the procedure will be evaluated by the endoscopist at the end of the procedure. Pictures of the markers will objectify the good placement of the markers.
- Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers
- The length of the procedure
- The costs (procedure, hospitalization)
- The clinical efficacy, by studying the decrease of the estimated target volume, the decrease of the dose delivered to the healthy tissue and the improvement of positioning of the irradiation beams by the radiotherapy technician
- The presence of the markers at the end of the radiotherapy
Read the detailed description
- Rational Cancers of the rectum and esophagus affect 15 000 and 4300 people per year in France (TNCD, the national digestive cancer thesaurus). Their prognosis remains bleak, particularly due to late diagnosis, with a 5-year survival rate of 10% for cancers of the esophagus and 55% at 5 years for rectal cancers (TNCD). When diagnosed at an advanced stage (> T2 or N +), treatment with radiotherapy +/- chemotherapy is indicated. The precise definition of macroscopic tumor volume in radiotherapy represents an important difficulty because it is based on endoscopic and imaging data obtained under conditions different from those used in the preparation of radiotherapy treatment. A better definition of the target tumor volume using radiopaque markers known as fiducial markers would be likely to improve the efficacy and tolerance of this treatment, or even to allow additional irradiation that would be targeted more precisely on the tumor.
- Objectives :
The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance.
The secondary objectives are to evaluate :
- Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers
- The length of the procedure
- The costs (procedure, hospitalization)
- The clinical efficacy, by studying the decrease of the estimated target volume, the decrease of the dose delivered to the healthy tissue and the improvement of positioning of the irradiation beams by the radiotherapy technician
- The presence of the markers at the end of the radiotherapy primary and secondary • Research methodology It is a prospective multicenter study, 18 centers will participate. Forty patients are to include over a period of 24 months.
- Conditions
- Esophageal Neoplasm, Rectal Neoplasms
- Being tested
- fiducial markers placement
- Medical subject headings
- Esophageal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiducial markers placementDevice
The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance for patients with esophageal or rectal cancer with an indication of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| fiducial markers placement | Experimental | Prospective study with one arm evaluating the feasibility of fiducial markers placement under echoendoscopic guidance, for patients with esophageal or rectal cancer Receives: Device: fiducial markers placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate evaluation of the placement of two fiducial markers
One marker in the upper part of the tumor and one in the lower part. Success of the procedure will be evaluated by the endoscopist at the end of the procedure. Pictures of the markers will objectify the good placement of the markers.
Measured: At the end of the endoscopic procedure, up to 2 hours
Secondary outcomes (5)
Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers
phone contact clinical examination at Day 1, clinical examination at day 30 and at the end of the radiotherapy treatment (day 90)
Measured: Day 1, Day 30 and Day 90
The length of the procedure
Duration in minutes of the endoscopic procedure
Measured: the endoscopic procedure, up to120 minutes
The costs (procedure, hospitalization)
sum of all costs : hospital stay, endoscopic procedure, fiducial markers
Measured: up to two days of hospitalization without any complication
The clinical efficacy, by studying the decrease of the estimated target volume, the decrease of the dose delivered to the healthy tissue
Before starting the radiotherapy, the target volume will be estimated with and without fiducial markers, thus estimating the decrease of the estimated target volume and the decrease of the dose delivered to the healthy tissue
Measured: Clinical examination with the radiotherapist, up to 30 minutes
The presence of the markers at the end of the radiotherapy
Visualization of the fiducial markers on CT scan or MRI
Measured: Clinical examination at the end of the radiotherapy with CT scan or MRI, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start3 Feb 2017
- Primary completion2 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective study with one single group of 40 patients
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Collaborators
- Cook Group Incorporated
- Responsible party
- Principal investigator, Chaput Ulriikka, Saint Antoine University Hospital
- Investigators
- Geoffroy VANBIERVLIET, M.D., Study chair, Nice University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057288
- Sponsor's protocol ID
- Etude SFED 115
- Acronym
- FIDECHO
- Status last verified
- Dec 2022
- First submitted
- 9 Feb 2017
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Camus M, Karsenti D, Levy J, Moreno M, Coron E, Esch A, Williet N, Wangermez M, Koch S, Valats JC, Pioche M, Becq A, Vanbiervliet G, Audureau E, Huguet F, Chaput U. Success rate of fiducial marker placement for treatment of esophageal or rectal cancers: a prospective multicenter study (FIDECHO study) (with video). Gastrointest Endosc. 2025 Mar;101(3):570-577. doi: 10.1016/j.gie.2024.08.014. Epub 2024 Aug 20.
PubMed 39173781
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Feasibility of Fiducial Markers Placement Under Echoendoscopy (EUS) Guidance for Patients With Esophageal or Rectal Cancer With an Indication of Radiotherapy
- ClinicalTrials.gov ID
- NCT03057288
- Acronym / sponsor ID
- FIDECHO / Etude SFED 115
- Conditions
- Esophageal Neoplasm, Rectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Collaborators
- Cook Group Incorporated
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 20 Feb 2017 (actual)
- 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.
It is a multicenter prospective observational study including consecutive patients with esophageal tumor or rectum with indication for radiotherapy
The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance. The evaluation criteria are:
- Success rate evaluation of the placement of two markers : one in the upper part of the tumor and one in the lower part. Success of the procedure will be evaluated by the endoscopist at the end of the procedure. Pictures of the markers will objectify the good placement of the markers.
- Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers
- The length of the procedure
- The costs (procedure, hospitalization)
- The clinical efficacy, by studying the decrease of the estimated target volume, the decrease of the dose delivered to the healthy tissue and the improvement of positioning of the irradiation beams by the radiotherapy technician
- The presence of the markers at the end of the radiotherapy
Detailed description
- Rational Cancers of the rectum and esophagus affect 15 000 and 4300 people per year in France (TNCD, the national digestive cancer thesaurus). Their prognosis remains bleak, particularly due to late diagnosis, with a 5-year survival rate of 10% for cancers of the esophagus and 55% at 5 years for rectal cancers (TNCD). When diagnosed at an advanced stage (> T2 or N +), treatment with radiotherapy +/- chemotherapy is indicated. The precise definition of macroscopic tumor volume in radiotherapy represents an important difficulty because it is based on endoscopic and imaging data obtained under conditions different from those used in the preparation of radiotherapy treatment. A better definition of the target tumor volume using radiopaque markers known as fiducial markers would be likely to improve the efficacy and tolerance of this treatment, or even to allow additional irradiation that would be targeted more precisely on the tumor.
- Objectives :
The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance.
The secondary objectives are to evaluate :
- Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers
- The length of the procedure
- The costs (procedure, hospitalization)
- The clinical efficacy, by studying the decrease of the estimated target volume, the decrease of the dose delivered to the healthy tissue and the improvement of positioning of the irradiation beams by the radiotherapy technician
- The presence of the markers at the end of the radiotherapy primary and secondary • Research methodology It is a prospective multicenter study, 18 centers will participate. Forty patients are to include over a period of 24 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective study with one single group of 40 patients
| Arm | Type | Receives |
|---|---|---|
| fiducial markers placement | Experimental | Device: fiducial markers placementProspective study with one arm evaluating the feasibility of fiducial markers placement under echoendoscopic guidance, for patients with esophageal or rectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients > 18 years
- Patients presenting an oesophageal or a rectal tumor passable with a linear echoendoscope
- TP> 60% et Platelets > 50 000/mm3
- No anticoagulant treatment or antiagregants being taken other than aspirin in the five days preceding the EUS
- Patient affiliated to a social security scheme (payee or beneficiary)
Key exclusion criteria (5 listed)
- Patient < 18 years
- Pregnant Woman
- Tumor stenosis impassable by the linear echoendoscope
- Patient participation refusal
- Patient under legal protection regime (guardianship / curatorship)
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 markers placementThe main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance for patients with esophageal or rectal cancer with an indication of radiotherapy | Device | fiducial markers placement |
Primary outcome
Success rate evaluation of the placement of two fiducial markers
Time frame: At the end of the endoscopic procedure, up to 2 hours
One marker in the upper part of the tumor and one in the lower part. Success of the procedure will be evaluated by the endoscopist at the end of the procedure. Pictures of the markers will objectify the good placement of the markers.
5 secondary outcomes
Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers
Time frame: Day 1, Day 30 and Day 90
The length of the procedure
Time frame: the endoscopic procedure, up to120 minutes
The costs (procedure, hospitalization)
Time frame: up to two days of hospitalization without any complication
The clinical efficacy, by studying the decrease of the estimated target volume, the decrease of the dose delivered to the healthy tissue
Time frame: Clinical examination with the radiotherapist, up to 30 minutes
The presence of the markers at the end of the radiotherapy
Time frame: Clinical examination at the end of the radiotherapy with CT scan or MRI, up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Derived from this study: PubMed 39173781Camus M, Karsenti D, Levy J, Moreno M, Coron E, Esch A, Williet N, Wangermez M, Koch S, Valats JC, Pioche M, Becq A, Vanbiervliet G, Audureau E, Huguet F, Chaput U. Success rate of fiducial marker placement for treatment of esophageal or rectal cancers: a prospective multicenter study (FIDECHO study) (with video). Gastrointest Endosc. 2025 Mar;101(3):570-577. doi: 10.1016/j.gie.2024.08.014. Epub 2024 Aug 20.
- Individual participant dataSharing planned: No
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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.
Geoffroy VANBIERVLIET, M.D. study chair
Nice University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fiducial markers placement in people with Esophageal Neoplasm and Rectal Neoplasms, run by Société Française d'Endoscopie Digestive at 1 site in France.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 5 Dec 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate evaluation of the placement of two fiducial markers (time frame: At the end of the endoscopic procedure, up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03057288, which also lists 1 linked publication.
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 5 Dec 2022.