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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Esophageal Neoplasm, Rectal Neoplasms

Intervention / Treatment
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* Device: fiducial markers placement


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective study with one single group of 40 patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fiducial markers placement<br>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<br>* 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<br>|

What is the study measuring?
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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 |