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

NCT05727553 | Unknown DMC

• 1 other identifier: IRB00002991
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Breast cancer; Radiotherapy; Online adaptive; Postoperative

Outcome Measures

Primary Outcomes (6)

• Time spend on the online adaptive workflow

  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.

  30 minutes

• Patient experience

  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.

  10 minutes

• Dosimetric data

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

  1 week

• DICOM images

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

  1 week

• Volumes

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

  1 week

• Number of monitor units (MU).

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

  1 week

Secondary Outcomes (1)

• Radiation associated toxicity

  Baseline, 1 month and 3 months after radiotherapy

Study Arms (1)

Breast cancer patients

Breast cancer patients treated with postoperative radiotherapy in an online adaptive workflow on Ethos.

Radiation: Online adaptive radiotherapy

Interventions

Online adaptive radiotherapy RADIATION

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.

Breast cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer patients undergoing postoperative radiation treatment.

You may qualify if:

• 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.

You may not qualify if:

• Patients not suitable for postoperative radiotherapy

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Desirée van den Bongard, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Rijksen, MD

CONTACT

+31650087496; b.rijksen@amsterdamumc.nl

Desirée van den Bongard, MD, PhD

CONTACT

h.j.vandenbongard@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: February 14, 2023
• Study Start: December 10, 2021
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)