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

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ClinicalTrials.gov Identifier: NCT03057288
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Cook Group Incorporated
Information provided by (Responsible Party):
Chaput Ulriikka, Saint Antoine University Hospital

Study Description
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Brief 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. 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

Condition or disease Intervention/treatment Phase
Esophageal Neoplasm Rectal Neoplasms Device: fiducial markers placement Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective study with one single group of 40 patients
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : February 3, 2017
Estimated Primary Completion Date : April 3, 2020
Estimated Study Completion Date : November 28, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. The length of the procedure [ Time Frame: the endoscopic procedure, up to120 minutes ]
    Duration in minutes of the endoscopic procedure

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057288


Contacts
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Contact: Ulriikka CHAPUT, M.D. +(33)149283170 ulriikka.chaput@hotmail.com
Contact: Françoise Robin francoise.robin@chu-lyon.fr

Locations
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France
Ulriikka CHAPUT Recruiting
Paris, France, 75012
Contact: Ulriikka CHAPUT, M.D.       ulriikka.chaput@hotmail.com   
Contact: Françoise ROBIN       francoise.robin@chu-lyon.fr   
Sponsors and Collaborators
Société Française d'Endoscopie Digestive
Cook Group Incorporated
Investigators
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Study Chair: Geoffroy VANBIERVLIET, M.D. Nice University hospital
More Information
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Responsible Party: Chaput Ulriikka, Dr Ulriikka CHAPUT MD, Saint Antoine University Hospital
ClinicalTrials.gov Identifier: NCT03057288    
Other Study ID Numbers: Etude SFED 115
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Neoplasms
Rectal Neoplasms
Esophageal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Head and Neck Neoplasms
Esophageal Diseases