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Radiation Oncology
Published in: Radiation Oncology 1/2020

01-12-2020 | Breast Cancer | Study protocol

Fatigue following radiotherapy of low-risk early breast cancer – a randomized controlled trial of intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy: the COSMOPOLITAN trial (NCT03838419)

Authors: Tobias Forster, Cornelia Jäkel, Sati Akbaba, David Krug, Robert Krempien, Matthias Uhl, Matthias Felix Häfner, Laila König, Stefan Alexander Koerber, Semi Harrabi, Denise Bernhardt, Rouven Behnisch, Johannes Krisam, Andre Hennigs, Christof Sohn, Jörg Heil, Jürgen Debus, Juliane Hörner-Rieber

Published in: Radiation Oncology | Issue 1/2020

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Abstract

Background

Fatigue is one of the most common and distressing side-effects of breast cancer radiotherapy. According to current guidelines, accelerated partial breast irradiation (APBI) may be considered as an alternative treatment option for women with early-stage low-risk breast cancer. One method for APBI is single-dose intraoperative radiotherapy (IORT) applied directly to the tumor bed during breast conserving surgery (BCS). The COSMOPOLITAN trial therefore aims to analyze the intensity of fatigue following single-shot IORT with electrons (IOERT) compared to conventional hypofractionated whole breast irradiation (WBI) in low risk early breast cancer patients.

Methods

This trial is conducted as a multicenter, prospective, randomized, two-arm phase II study comparing the intensity of fatigue in early-stage breast cancer (cT1cN0cM0, tumor size < 2,5 cm, ER pos. Her2neu neg., age > 50 years) treated either with WBI or APBI after BCS. Secondary outcomes investigated are tumor control, overall survival (OS), disease-free survival (DFS), acute and chronic toxicity, quality of life (QoL) and cosmesis. A total of 202 patients will be randomized into two arms: Patients in arm A will receive WBI (40.05 Gy, 15 fractions) after surgical resection, while patients in arm B will receive IOERT (21 Gy to the 90%-isodose) during BCS. Fatigue will be assessed 12 weeks post surgery with the help of the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.

Discussion

The present trial aims to evaluate treatment response to compare single-shot intraoperative electron APBI to conventional WBI following BCS in early-stage low risk breast cancer patients. Fatigue is selected as the primary, patient-reported endpoint due its major clinical relevance.

Trial registration

The study is prospectively registered on February 12th, 2019: Clinicaltrials.gov, NCT03838419. “Intraoperative Electron Radiotherapy for Low-risk Early Breast Cancer (COSMOPOLITAN)”.

Study status

Ongoing study. Start of recruitment was December 2019.
Appendix
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Metadata
Title
Fatigue following radiotherapy of low-risk early breast cancer – a randomized controlled trial of intraoperative electron radiotherapy versus standard hypofractionated whole-breast radiotherapy: the COSMOPOLITAN trial (NCT03838419)
Authors
Tobias Forster
Cornelia Jäkel
Sati Akbaba
David Krug
Robert Krempien
Matthias Uhl
Matthias Felix Häfner
Laila König
Stefan Alexander Koerber
Semi Harrabi
Denise Bernhardt
Rouven Behnisch
Johannes Krisam
Andre Hennigs
Christof Sohn
Jörg Heil
Jürgen Debus
Juliane Hörner-Rieber
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Radiation Oncology / Issue 1/2020
Electronic ISSN: 1748-717X
DOI
https://doi.org/10.1186/s13014-020-01581-9

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