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NCT06317272 Clinical Trial

BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma

Esophageal Cancer Clinical Trial

— BROTHER  

Official title:
BReath hOld TecHniquEs for Radiotherapy of Esophageal Carcinoma; a Feasibility Study - Part 1

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT06317272
Other study ID # RT2016-04-BROTHER Part 1
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 10, 2021
Est. completion date September 19, 2023

Study information
Verified date March 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study.

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date September 19, 2023
Est. primary completion date September 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically proven esophageal cancer of the mid or distal esophagus - Scheduled for external-beam photon radiotherapy with curative intention. - WHO 0-2. - Age >= 18 years - Written informed consent. Exclusion Criteria: - Serious respiratory distress - Contra-indication for fiducial marker placement - Noncompliance with any of the inclusion criteria

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• DIBH using ABC technique
Deep breath inspiration hold (DIBH) using Active Breathing Control (ABC) technique
• DIBH using VC technique
Deep breath inspiration hold (DIBH) using Voluntary Coaching (VC) technique

Locations
Country Name City State
Netherlands UMC Groningen Groningen

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility DIBH Breath hold maintained for >20 seconds Week 1, 2, 3, 4, 5 during radiotherapy
Primary Reproducibility DIBH Diaphragm dome position within 1cm of the baseline CT Target coverage >94% of the prescribed dose (at 98% of the ITV) Week 1, 2, 3, 4, 5 during radiotherapy
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