Prospective Study Evaluating the Feasibility of Fiducial Markers Placement for Patients With Esophageal or Rectal Cancer (FIDECHO)

December 2, 2022 updated by: Chaput Ulriikka, Société Française d'Endoscopie Digestive

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Ulriikka CHAPUT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient < 18 years
  • Pregnant Woman
  • Tumor stenosis impassable by the linear echoendoscope
  • Patient participation refusal
  • Patient under legal protection regime (guardianship / curatorship)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: fiducial markers placement
Prospective study with one arm evaluating the feasibility of fiducial markers placement under echoendoscopic guidance, for patients with esophageal or rectal cancer
Device: fiducial markers placement
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At the end of the endoscopic procedure, up to 2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
phone contact clinical examination at Day 1, clinical examination at day 30 and at the end of the radiotherapy treatment (day 90)
Day 1, Day 30 and Day 90
The length of the procedure
Time Frame: the endoscopic procedure, up to120 minutes
Duration in minutes of the endoscopic procedure
the endoscopic procedure, up to120 minutes
The costs (procedure, hospitalization)
Time Frame: up to two days of hospitalization without any complication
sum of all costs : hospital stay, endoscopic procedure, fiducial markers
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
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
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
Visualization of the fiducial markers on CT scan or MRI
Clinical examination at the end of the radiotherapy with CT scan or MRI, up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société Française d'Endoscopie Digestive

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cook Group Incorporated

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Geoffroy VANBIERVLIET, M.D., Nice University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Etude SFED 115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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