Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years

Summary

This study will evaluate the effect of highly accelerated external beam radiotherapy (EBRT) in 5 fractions over 10 days compared to 15 fractions over 3 weeks for early as well as locally-advanced stage breast cancer.

Primary endpoint will be chronic toxicity (breast deformation and retraction). Secondary endpoints are acute toxicity, loco-regional and distant tumor control, patient reported QoL and cosmetic satisfaction. Patients with lymph node irradiation will be closely monitored for radiation induced plexopathy.

Conditions

• Breastcancer

Interventions

RADIATION

WBI 5 fractions

External beam radiotherapy in 5 fractions of 5,7Gy

RADIATION

WBI 15 fractions

External beam radiotherapy in 15 fractions of 2,67Gy

RADIATION

LNI 5 fractions

External beam radiotherapy in 5 fractions of 5,4Gy

RADIATION

LNI 15 fractions

External beam radiotherapy in 15 fractions of 2,67Gy

RADIATION

SIB 5 fractions if needed

Simultaneous boost of 5 x 6,2Gy (6,5Gy in case of involved resection margins) if needed

RADIATION

SIB 15 fractions if needed

Simultaneous boost of 15x3,12Gy (3,33Gy in case of involved resection margins) if needed

RADIATION

TWI 5 fractions

External beam radiotherapy in 5 fractions of 5,7Gy

RADIATION

TWI 15 fractions

External beam radiotherapy in 15 fractions of 2,67Gy

Sponsors & Collaborators

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• Liv Veldeman, M.D., PhD · Ghent University Hospital, Dept. Radiotherapy-Oncology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-15

Primary Completion

2021-11-15

Completion

2026-11-15

Countries

• Belgium

Study Locations