Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum
FIDUCOR
1 other identifier
interventional
29
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 25, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMarch 3, 2017
February 1, 2016
2.8 years
June 25, 2015
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Observing whether there is a significant variation of the area to be irradiated
From inclusion to 12 months follow up
Secondary Outcomes (1)
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)
From inclusion to 12 months follow up
Study Arms (1)
Laying of medical devices
EXPERIMENTALradio opaque markers
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Paoli-Calmetteslead
- Cook medical laboratorycollaborator
Study Sites (1)
Institut Paoli-Calmettes
Marseille, 13273, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2015
First Posted
August 18, 2015
Study Start
April 1, 2014
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
March 3, 2017
Record last verified: 2016-02