Skip to main content
Clinical Trials/NCT05727553
NCT05727553
Recruiting
Not Applicable

Implementation of Online Adaptive Radiotherapy for Breast Cancer Patients on Ethos

Amsterdam UMC, location VUmc1 site in 1 country50 target enrollmentDecember 10, 2021
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Amsterdam UMC, location VUmc
Enrollment
50
Locations
1
Primary Endpoint
DICOM images
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2021
End Date
March 1, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Amsterdam UMC, location VUmc
Responsible Party
Principal Investigator
Principal Investigator

H.J.G.D. van den Bongard

Principal Investigator

Amsterdam UMC, location VUmc

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

Outcomes

Primary Outcomes

DICOM images

Time Frame: 1 week

DICOM images of the standard offline treatment plan (reference plan), scheduled plan and the online adapted treatment plan (adapted plan) will be compared.

Volumes

Time Frame: 1 week

Target volumes of clinical target volume (CTV), planning target volume (PTV), coverage of CTV and PTV will be registred in cubic centimetres.

Dosimetric data

Time Frame: 1 week

The dosimetric data of the standard offline treatment plan (reference plan), scheduled plan and the online adapted treatment plan (adapted plan) will be compared.

Number of monitor units (MU).

Time Frame: 1 week

The number of monitor units (MU) will be compared between the reference treatment plan, scheduled plan and adapted treatment plan.

Patient experience

Time Frame: 10 minutes

Patient experience is measured using an in-house designed short study questionnaire after the first and the last radiation fraction. The questionnaires is on a 4-point Likert scale with a lowest score for discomfort and the highest score appears for good comfort.

Time spend on the online adaptive workflow

Time Frame: 30 minutes

All separate parts of the online adaptive workflow will be registered in minutes, starting when the patients enters the room of the radiation machine until the patient leaves the room.

Secondary Outcomes

  • Radiation associated toxicity(Baseline, 1 month and 3 months after radiotherapy)

Study Sites (1)

Loading locations...

Similar Trials