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A phase II trial to determine the cosmetic outcomes and toxicity of 27 Gy in five-fraction accelerated partial breast irradiation: the ACCEL trial

  • Study Protocol
  • Published:
Journal of Radiation Oncology

Abstract

Background

Accelerated partial breast irradiation (APBI) has been investigated in randomized controlled trials with the goals of reducing side effects and treatment burden. There is accumulating evidence that local control for multi-fraction APBI is not inferior to whole breast irradiation (WBI) but an external beam prescription that can be safely delivered in five consecutive days has not been reported. The aim of this study is to investigate an APBI prescription delivered once per day in 1 week.

Methods

This is a single-arm, phase II, prospective cohort study. Two hundred seventy-four eligible women with newly diagnosed, early-stage, invasive, or in situ ductal carcinoma treated with breast-conserving surgery and sentinel lymph node biopsy or axillary dissection who are candidates for whole breast radiation without a boost will be recruited. Twenty-seven Gray (Gy) in five fractions will be delivered once daily over five consecutive working days to the target volume. The primary outcome is the rate of global cosmetic deterioration from an excellent or good score at baseline (prior to radiation therapy) to a fair or poor score at 2 years after treatment. The study is powered to demonstrate non-inferiority compared to the use of WBI arm in the RAPID trial.

Discussion

The ACCEL trial aims to demonstrate the safe and effective delivery of a five-fraction APBI treatment using IMRT or 3D-conformal radiation. The study is designed to account for an updated α/β ratio for breast tissue and compares cosmesis to the WBI arm of the RAPID trial. The ACCEL trial was registered in February 2016 and began accrual in the subsequent May.

Conclusions

This trial will assess the cosmetic and normal tissue outcomes of external beam APBI delivered in 1 week for early-stage breast cancer.

Trial registration

Registration number: NCT02681107 (clinicaltrials.gov), registered February 2, 2016.

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Abbreviations

BCS:

breast conserving surgery

WBI:

whole breast irradiation

IBTR:

ipsilateral breast tumor recurrence

RT:

radiation therapy

APBI:

accelerated partial breast irradiation

RCT:

randomized control trials

NSABP:

National Surgical Adjuvant Breast and Bowel Project

RTOG:

radiation therapy oncology group

IMRT:

intensity-modulated radiation therapy

CT:

computed tomography

EORTC:

European Organization for Research and Treatment of Cancer

GTV:

gross tumor volume

CTV:

clinical target volume

PTV:

planning target volume

DEV:

dose-evaluation volume

CBCT:

cone-beam CT

CTDIw :

weighted computed tomography dose index

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Acknowledgements

The authors would like to acknowledge the support from Nicole Valade from the Trial launch team and the Tom Baker Cancer Centre Clinical Trials Unit team for trial initiation assistance.

Author information

Authors and Affiliations

  1. Department of Oncology, University of Calgary, Calgary, Alberta, Canada

    Petra Grendarova, Sarah Quirk, Michael Roumeliotis, Hongwei Liu, Peter Craighead, Jane Wilson, Tien Phan & Ivo A. Olivotto

  2. Division of Radiation Oncology, Tom Baker Cancer Centre, 1331 29th Street NW, Calgary, Alberta, T2N 4N2, Canada

    Petra Grendarova, Hongwei Liu, Peter Craighead, Jane Wilson, Tien Phan & Ivo A. Olivotto

  3. Tom Baker Cancer Centre, 1331 29th Street NW, Calgary, Alberta, T2N 4N2, Canada

    Petra Grendarova, Sarah Quirk, Michael Roumeliotis, Mark Lesiuk, Tammy Austin, Katelyn Bignell, Peter Craighead, Tien Phan & Ivo A. Olivotto

  4. Division of Medical Physics, Tom Baker Cancer Centre, 1331 29th Street NW, Calgary, Alberta, T2N 4N2, Canada

    Sarah Quirk & Michael Roumeliotis

  5. Central Alberta Cancer Centre, 3942 50a Ave, Red Deer, Alberta, T4N 4E7, Canada

    Hongwei Liu

  6. Jack Ady Cancer Centre, 960 19 St S, Lethbridge, Alberta, T1J 1W5, Canada

    Jane Wilson

Authors
  1. Petra Grendarova
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  2. Sarah Quirk
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  3. Michael Roumeliotis
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  4. Mark Lesiuk
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  5. Tammy Austin
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  7. Hongwei Liu
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  8. Peter Craighead
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  9. Jane Wilson
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  10. Tien Phan
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  11. Ivo A. Olivotto
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Contributions

PG made substantial contributions to the study concept and protocol design, is a co-principal investigator, and she was mainly responsible for drafting the manuscript. IO made substantial contributions to the study concept and protocol design, he is a co-principal investigator, and he has made substantial contributions to manuscript writing. MR is a co-investigator and a lead medical physicist on the study. He has made substantial contribution to study concept and protocol design and has been involved in revising the manuscript critically for important intellectual content. SQ has been involved in IMRT planning strategy design of the study. She has been involved in drafting the manuscript and revising the manuscript critically for important intellectual content. ML is a primary study coordinator and has been involved in the implementation of the study, acquisition of data, and database management. KB is a study coordinator, and she has been involved in the implementation of the study, acquisition of data, and database management. TA is a primary study dosimetrist; she has been involved in protocol design and IMRT planning implementation. HL has made substantial contribution to study concept and protocol design and acquisition of data and has been involved in revising manuscript critically for important intellectual content. PC has made substantial contribution to study concept and protocol design and acquisition of data and has been involved in revising the manuscript critically for important intellectual content. JW has made substantial contribution to study concept and protocol design and acquisition of data and has been involved in revising manuscript critically for important intellectual content. TP has made substantial contribution to study concept and protocol design and acquisition of data and has been involved in revising manuscript critically for important intellectual content. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Petra Grendarova.

Ethics declarations

Funding

The study is supported by an Investigator Initiated Trials program grant from the Tom Baker Cancer Centre funded by the Alberta Cancer Foundation (11629-27/5-01), Alberta, Canada.

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

All human and animal studies have been approved by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. All applicable international, national, and/or institutional guidelines for the care and use of animals were followed. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study’s ethics proposal was reviewed and approved by Health Research Ethics Board of Alberta (protocol identifying number: HREBA.CC16-006).

Informed consent

Informed consent was obtained from all individual participants included in the study.

Consent for publication

Not applicable.

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Grendarova, P., Quirk, S., Roumeliotis, M. et al. A phase II trial to determine the cosmetic outcomes and toxicity of 27 Gy in five-fraction accelerated partial breast irradiation: the ACCEL trial. J Radiat Oncol 7, 285–291 (2018). https://doi.org/10.1007/s13566-018-0359-2

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  • DOI: https://doi.org/10.1007/s13566-018-0359-2

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