Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum (FIDUCOR)

March 1, 2017 updated by: Institut Paoli-Calmettes
The purpose of this study is to estimate the rate of patients in whom a significant change in the area to be irradiated will be observed between the assessment before and after laying the evaluation of Trustees.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The centering of radiotherapy is done with the pre-radiation scanner for tracking the implementation of target skin markers. On this scanner, it is often difficult for the radiation therapist to pinpoint the target volume. To improve the definition of the target volume, image fusion techniques with other imaging tests were developed.

To improve the pre-radiotherapy identification, setting up markers echo-endoscopy has been described without major complications. The impact on targeting radiotherapy was mainly described for the prostate.

The marking of digestive tumors was described by the establishment of Trustees, radiopaque markers in the lymph nodes, esophagus, stomach, pancreas, and bile ducts.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2

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
      • Marseille, France, 13273
        • Institut Paoli-Calmettes

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Male or female over the age of 18
  • Rectal cancer diagnosis or esophagus
  • Radiotherapy indication
  • Signed consent to participate
  • Patient affiliated to a social security system or benefiting from such a system

Exclusion Criteria:

  • Pregnant women, of child-bearing potential, or lactating women
  • Patient deprived of liberty or under supervision of a guardian
  • Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
  • Contra-indication for procedure study (infeasible EUS)
  • Contra-indication for general anesthesia
  • Patient (e) with disorders of hemostasis
  • Patient (e) with portal hypertension

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laying of medical devices
radio opaque markers
Device: radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients rate in which a significant variation in the area to be irradiated will be observed between before evaluation and evaluation after laying the trustees.
Time Frame: From inclusion to 12 months follow up
Observing whether there is a significant variation of the area to be irradiated
From inclusion to 12 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of trustees (2 up 6 maximum) and set up their positions estimated success rate of implementation and the evaluation of the safety and toxicity (complications) associated with the establishment trustees (composite measure)
Time Frame: From inclusion to 12 months follow up
Safety and security are measured by statistical analysis (numbers and percentage for qualitative variables and by average, median, standard deviations and extreme values for quantitative variables.
From inclusion to 12 months follow up

Collaborators and Investigators

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

Sponsor

Institut Paoli-Calmettes

Collaborators

Cook medical laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

April 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIDUCOR-IPC 2013-008

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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