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Trial Title:
Implementation of Online Adaptive Radiotherapy for Breast Cancer Patients on Ethos (BREAST-ART)
NCT ID:
NCT05727553
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Radiotherapy
Online adaptive
Postoperative
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
Online adaptive radiotherapy
Description:
Postoperative radiotherapy will be indicated conform the standard medical care and
guidelines. The radiation is delivered with online adaptive radiotherapy performed on the
Ethos. This technique will be evaluated.
Arm group label:
Breast cancer patients
Summary:
Postoperative radiotherapy is for the majority of breast cancer patients the standard of
care. During postoperative radiotherapy, unexpected dosimetric deviations can occur due
to breast contour changes resulting from resorption of postoperative breast or chest wall
seroma/hematoma, oedema either postoperatively or during irradiation, or arm/body
positioning variation. In approximately 10% of cases, repositioning after setup imaging
is not sufficient, and offline plan adaptation is required. When a new treatment planning
is required in the standard offline workflow this will take in general 2 days. By using
an online adaptive workflow with a daily treatment planning this delay and extra work
caused by offline plan adaptation can be omitted. The aim of this study is to translate
the offline adaptive workflow to an online adaptive workflow, and investigate the
experiences of patients who have been treated with online adaptive radiotherapy for
breast cancer (BREAST-ART).
Detailed description:
In this single-arm prospective BREAST-ART study breast cancer patients with an indication
for postoperative radiotherapy will be treated according to the Dutch and institutional
guidelines. Target volumes will be the whole breast, chest wall, axillary levels, tumor
bed boost and partial breast irradiation on the right side and left side with a deep
inspiration breath hold technique. Robust templates are developed for offline and online
treatment planning with an IMRT tangential multiple-beam setup. A simulation of the
online adaptive workflow is performed in breast cancer patients already treated on the
Ethos-linac with the standard offline adaptive workflow. Patients will be treated
following the online adaptive workflow delivered on the Ethos-Linac. Patient experience
will be evaluated using an in-house developed questionnaires after the first and last
fraction, scoring treatment satisfaction on a 4-point Likert scale. Furthermore, all
dosimetric data, volume details, DICOM images and the time spend on all parts of the
online adaptive workflow will be evaluated.
Criteria for eligibility:
Study pop:
Breast cancer patients undergoing postoperative radiation treatment.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Breast cancer patients referred for postoperative radiotherapy of the breast, chest
wall, axillary levels, tumor bed boost or partial breast irradiation.
- Age of 18 years and older.
- Adequate understanding and communicating the Dutch language.
- Written informed consent for use of routinely collected clinical data and to fill
out questionnaires.
Exclusion Criteria:
- Patients not suitable for postoperative radiotherapy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Barbara Rijksen, MD
Phone:
+316500087496
Email:
b.rijksen@amsterdamumc.nl
Start date:
December 10, 2021
Completion date:
March 1, 2024
Lead sponsor:
Agency:
Amsterdam UMC, location VUmc
Agency class:
Other
Source:
Amsterdam UMC, location VUmc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05727553
