Clinical trial NCT05727553: Implementation of Online Adaptive Radiotherapy for Breast Cancer Patients on Ethos (BREAST-ART)
Official title: Implementation of Online Adaptive Radiotherapy for Breast Cancer Patients on Ethos
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast cancer
Radiotherapy
Online adaptive
Postoperative
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients undergoing postoperative radiation treatment.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Time spend on the online adaptive workflow
timeFrame: 30 minutes
measure: Patient experience
timeFrame: 10 minutes
measure: Dosimetric data
timeFrame: 1 week
measure: DICOM images
timeFrame: 1 week
measure: Volumes
timeFrame: 1 week
measure: Number of monitor units (MU).
timeFrame: 1 week
Secondary outcomes:
measure: Radiation associated toxicity
timeFrame: Baseline, 1 month and 3 months after radiotherapy
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Desirée van den Bongard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: