BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma

Not Applicable

Terminated

• Conditions: Esophageal Cancer

• Registration Number: NCT06317272
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-10
• Primary Completion: 2023-09-19
• Study Completion: 2023-09-19
• Study First Submitted: 2024-02-27
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-11
• Last Update Submitted: 2024-03-11
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Reproducibility DIBH	Week 1, 2, 3, 4, 5 during radiotherapy	Diaphragm dome position within 1cm of the baseline CT Target coverage \>94% of the prescribed dose (at 98% of the ITV)
Feasibility DIBH	Week 1, 2, 3, 4, 5 during radiotherapy	Breath hold maintained for \>20 seconds

Trial Locations

Locations (1)

UMC Groningen; 🇳🇱 Groningen, Netherlands