NCT03121248

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Over the age of 65, uptake of adjuvant radiotherapy after surgery for breast cancer declines, even in women with poor prognostic stage or adverse tumor characteristics. Lowering the number of fractions may reduce reluctancy for radiotherapy in this age group. In a preceding prospective phase I-II trial, evaluating EBRT over 10 days, results on technical feasibility and acute toxicity were positively evaluated. However, data on the chronic effects of breast irradiation using high doses per fraction are still sparse. This trial is developed to compare standard hypo-fractionation in 15 fractions (if needed with simultaneously integrated boost - SIB) with highly accelerated radiotherapy in 5 fractions. Patients referred for adjuvant radiotherapy after breast conserving surgery will preferably be randomized, depending on the indication, to a study-arm with whole breast irradiation (WBI) +/- SIB or to a study-arm with WBI+/- SIB and lymph node irradiation (LNI). If patients after breast conserving surgery (BCS) have a strong preference for 5 or 15 fractions, they will be invited to enter the parallel observational arm (patient preference). Patients referred for adjuvant radiotherapy after mastectomy +/- LNI accepting to participate, can choose a 5 or 15-fraction schedule. No randomization is foreseen in this last observational group.

Conditions

• Breastcancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-02-15
• Primary completion: 2021-11-15
• Completion: 2026-11-15
• First posted: 2017-04-20
• Last updated: 2023-12-22

Locations

1 site across 1 country: Belgium