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Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years
Sponsor: University Hospital, Ghent
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
WBI 5 fractions
External beam radiotherapy in 5 fractions of 5,7Gy
WBI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
LNI 5 fractions
External beam radiotherapy in 5 fractions of 5,4Gy
LNI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
SIB 5 fractions if needed
Simultaneous boost of 5 x 6,2Gy (6,5Gy in case of involved resection margins) if needed
SIB 15 fractions if needed
Simultaneous boost of 15x3,12Gy (3,33Gy in case of involved resection margins) if needed
TWI 5 fractions
External beam radiotherapy in 5 fractions of 5,7Gy
TWI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
Locations (1)
Ghent University Hospital, Dept. Radiotherapy-Oncology
Ghent, Belgium