Neoplasms

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Breast Neoplasms

Breast Diseases

Skin Diseases

WBI 5 fractions SIB 5 fractions if needed

WBI 15 fractions SIB 15 fractions if needed

WBI 5 fractions SIB 5 fractions if needed LNI 5 fractions

WBI 15 fractions SIB 15 fractions if needed LNI 15 fractions

TWI 5 fractions SIB 5 fractions if needed LNI 5 fractions

TWI 15 fractions SIB 15 fractions if needed LNI 15 fractions

External beam radiotherapy in 5 fractions of 5,7Gy

WBI 5 fractions

External beam radiotherapy in 15 fractions of 2,67Gy

WBI 15 fractions

External beam radiotherapy in 5 fractions of 5,4Gy

LNI 5 fractions

LNI 15 fractions

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

SIB 5 fractions if needed

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

SIB 15 fractions if needed

TWI 5 fractions

TWI 15 fractions

Liv Veldeman, M.D., PhD

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.

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.

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

Patients can accept clinical trial but refuse randomization. In this case they will be allocated to a patient preference study arm, existing also of a 5 or 15 fraction-schedule. The choice of the patient: acceptance or non-acceptance of study, acceptance or non-acceptance of randomization, in case of patient preference arm: acceptance or 5 or 15 fractions.

Measurement of frailty using G8 geriatric screening tool

Cost effectiveness analysis comparing 5 with 15 fractions

Percentage of patients able to perform prone positioning on new breast board: yes or no.

Percentage of patients able to perform breath-hold procedure in prone position: yes or no.

Breast Cancer Conservative treatment.core (BCCT.core) objective measurement

Grade 1: mild; Grade 2: moderate, limiting activity of daily living (ADL); grade 3: severe, limiting ADL

Grade 1: mild, localized topical intervention; Grade 2: intense, oral intervention, skin changes

BREAST-Q questionnaire: Patient reported outcome, evaluating satisfaction with esthetic outcome.

If a screening reveals unilateral pain, loss of function or muscular atrophy in the ipsilateral arm, an EMG will be performed to confirm/exclude RIBP

Ipsilateral or regional breast recurrence

Number of patients alive and without breast cancer recurrence at 2 and 5 years after adjuvant radiotherapy

Number of patients alive, 2 and 5 years after adjuvant radiotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years	NCT03121248	Breastcancer	WBI 5 fractions WBI 15 fraction... LNI 5 fractions LNI 15 fraction... SIB 5 fractions... SIB 15 fraction... TWI 5 fractions TWI 15 fraction...	65 Years -	University Hospital, Ghent
Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years	NCT03121248	Breastcancer	WBI 5 fractions WBI 15 fraction... LNI 5 fractions LNI 15 fraction... SIB 5 fractions... SIB 15 fraction... TWI 5 fractions TWI 15 fraction...	65 Years -	University Hospital, Ghent

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