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

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: Completed
• Conditions: Rectal Neoplasms; Esophageal Neoplasm
• Intervention / Treatment: Device: fiducial markers placement

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75012
    • Ulriikka CHAPUT

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	At the end of the endoscopic procedure, up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 1, Day 30 and Day 90
The length of the procedure	Duration in minutes of the endoscopic procedure	the endoscopic procedure, up to120 minutes
The costs (procedure, hospitalization)	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	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	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

• Sponsor: Société Française d'Endoscopie Digestive
• Collaborators: Cook Group Incorporated
• Investigators: Study Chair: Geoffroy VANBIERVLIET, M.D., Nice University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2017
• Primary Completion (Actual): September 2, 2021
• Study Completion (Actual): September 2, 2021

Study Registration Dates

• First Submitted: February 9, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Esophageal Diseases; Colorectal Neoplasms; Neoplasms; Rectal Neoplasms; Esophageal Neoplasms
• Other Study ID 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