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BMC Cancer
Published in: BMC Cancer 1/2017

Open Access 01-12-2017 | Study protocol

Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol

Authors: R. K. Charaghvandi, B. van Asselen, M. E. P. Philippens, H. M. Verkooijen, C. H. van Gils, P. J. van Diest, R. M. Pijnappel, M. G. G. Hobbelink, A. J. Witkamp, T. van Dalen, E. van der Wall, T. C. van Heijst, R. Koelemij, M. van Vulpen, H. J. G. D. van den Bongard

Published in: BMC Cancer | Issue 1/2017

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Abstract

Background

A shift towards less burdening and more patient friendly treatments for breast cancer is currently ongoing. In low-risk patients with early-stage disease, accelerated partial breast irradiation (APBI) is an alternative for whole breast irradiation following breast-conserving surgery. MRI-guided single dose ablative APBI has the potential to offer a minimally burdening, non-invasive treatment that could replace current breast-conserving therapy.

Methods

The ABLATIVE study is a prospective, single arm, multicenter study evaluating preoperative, single dose, ablative radiation treatment in patients with early-stage breast cancer. Patients with core biopsy proven non-lobular invasive breast cancer, (estrogen receptor positive, Her2 negative, maximum tumor size 3.0 cm on diagnostic MRI) and a negative sentinel node biopsy are eligible. Radiotherapy (RT) planning will be performed using a contrast enhanced (CE) planning CT-scan, co-registered with a CE-MRI, both in supine RT position. A total of twenty-five consecutive patients will be treated with a single ablative RT dose of 20 Gy to the tumor and 15 Gy to the tumorbed. Follow-up MRIs are scheduled within 1 week, 2, 4 and 6 months after single-dose RT. Breast-conserving surgery is scheduled at six months following RT.
Primary study endpoint is pathological complete response. Secondary study endpoints are the radiological response and toxicity. Furthermore, patients will fill out questionnaires on quality of life and functional status. Cosmetic outcome will be evaluated by the treating radiation oncologist, patient and ‘Breast Cancer Conservation Treatment cosmetic results’ software. Recurrence and survival rates will be assessed. The patients will be followed up to 10 years after diagnosis. If patients give additional informed consent, a biopsy and a part of the irradiated specimen will be stored at the local Biobank and used for future research on radiotherapy response associated genotyping.

Discussion

The ABLATIVE study evaluates MRI-guided single dose ablative RT in patients with early-stage breast cancer, aiming at a less burdening and non-invasive alternative for current breast-conserving treatment.

Trial registration

ClinicalTrials.gov registration number NCT02316561. The trial was registrated prospectively on October 10th 2014.
Appendix
Available only for authorised users
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Metadata
Title
Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol
Authors
R. K. Charaghvandi
B. van Asselen
M. E. P. Philippens
H. M. Verkooijen
C. H. van Gils
P. J. van Diest
R. M. Pijnappel
M. G. G. Hobbelink
A. J. Witkamp
T. van Dalen
E. van der Wall
T. C. van Heijst
R. Koelemij
M. van Vulpen
H. J. G. D. van den Bongard
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2017
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-017-3144-5

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