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ACTIVE NOT RECRUITING
NCT03121248
NA

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

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

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.

Official title: A Partially Randomized Patient Preference Trial, Comparing Adjuvant Hypofractionated Radiotherapy in 15 Versus 5 Fractions After Breast Conserving Surgery or Mastectomy for Early or Locally Advanced Breast Cancer in Women Above 65 Years

Key Details

Gender

FEMALE

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2017-02-15

Completion Date

2026-11-15

Last Updated

2023-12-22

Healthy Volunteers

No

Conditions

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

Locations (1)

Ghent University Hospital, Dept. Radiotherapy-Oncology

Ghent, Belgium