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Implementation of Online Adaptive Radiotherapy for Breast Cancer Patients on Ethos (BREAST-ART) (BREAST-ART)

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ClinicalTrials.gov Identifier: NCT05727553
Recruitment Status : Recruiting
First Posted : February 14, 2023
Last Update Posted : February 23, 2023
Sponsor:
Information provided by (Responsible Party):
H.J.G.D. van den Bongard, Amsterdam UMC, location VUmc

Study Description
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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).

Condition or disease Intervention/treatment
Breast Cancer Radiation: Online adaptive radiotherapy

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Implementation of Online Adaptive Radiotherapy for Breast Cancer Patients on Ethos
Actual Study Start Date : December 10, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Breast cancer patients
Breast cancer patients treated with postoperative radiotherapy in an online adaptive workflow on Ethos.
 Radiation: Online adaptive radiotherapy
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Radiation associated toxicity [ Time Frame: Baseline, 1 month and 3 months after radiotherapy ]
    Toxicity will be assessed by the Common Terminology Criteria Adverse Events version 5.0.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast cancer patients undergoing postoperative radiation treatment.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05727553


Contacts
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Contact: Barbara Rijksen, MD +31650087496 b.rijksen@amsterdamumc.nl
Contact: Desirée van den Bongard, MD, PhD h.j.vandenbongard@amsterdamumc.nl

Locations
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Netherlands
Amsterdam UMC Recruiting
Amsterdam, Noord Holland, Netherlands, 1081 HV
Contact: Barbara Rijksen, MD    +316500087496    b.rijksen@amsterdamumc.nl   
Sponsors and Collaborators
Amsterdam UMC, location VUmc
Investigators
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Principal Investigator: Desirée van den Bongard, MD, PhD Amsterdam UMC, location VUmc
More Information
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Responsible Party: H.J.G.D. van den Bongard, Principal Investigator, Amsterdam UMC, location VUmc
ClinicalTrials.gov Identifier: NCT05727553    
Other Study ID Numbers: IRB00002991
First Posted: February 14, 2023    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H.J.G.D. van den Bongard, Amsterdam UMC, location VUmc:
Breast cancer
Radiotherapy
Online adaptive
Postoperative
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases