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

Rectal Cancer Clinical Trial

— FIDUCOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526134
• Other study ID #: FIDUCOR-IPC 2013-008
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2015
• Last updated: March 1, 2017
• Start date: April 2014
• Est. completion date: January 2017

Study information

• Verified date: February 2016
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Oesophageal Cancer
• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	Cook medical laboratory

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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

External Links

•   official web site of the sponsor