Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years
NCT ID: NCT03121248
Last Updated: 2023-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
144 participants
INTERVENTIONAL
2017-02-15
2026-11-15
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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WBI - randomized - 5
WBI 5 fractions SIB 5 fractions if needed
WBI 5 fractions
External beam radiotherapy in 5 fractions of 5,7Gy
SIB 5 fractions if needed
Simultaneous boost of 5 x 6,2Gy (6,5Gy in case of involved resection margins) if needed
WBI - randomized - 15
WBI 15 fractions SIB 15 fractions if needed
WBI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
SIB 15 fractions if needed
Simultaneous boost of 15x3,12Gy (3,33Gy in case of involved resection margins) if needed
WBI - observational - 5
WBI 5 fractions SIB 5 fractions if needed
WBI 5 fractions
External beam radiotherapy in 5 fractions of 5,7Gy
SIB 5 fractions if needed
Simultaneous boost of 5 x 6,2Gy (6,5Gy in case of involved resection margins) if needed
WBI - observational - 15
WBI 15 fractions SIB 15 fractions if needed
WBI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
SIB 15 fractions if needed
Simultaneous boost of 15x3,12Gy (3,33Gy in case of involved resection margins) if needed
WBI + LNI - randomized - 5
WBI 5 fractions SIB 5 fractions if needed LNI 5 fractions
WBI 5 fractions
External beam radiotherapy in 5 fractions of 5,7Gy
LNI 5 fractions
External beam radiotherapy in 5 fractions of 5,4Gy
SIB 5 fractions if needed
Simultaneous boost of 5 x 6,2Gy (6,5Gy in case of involved resection margins) if needed
WBI + LNI - randomized - 15
WBI 15 fractions SIB 15 fractions if needed LNI 15 fractions
WBI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
LNI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
SIB 15 fractions if needed
Simultaneous boost of 15x3,12Gy (3,33Gy in case of involved resection margins) if needed
WBI with LNI - observational - 5
WBI 5 fractions SIB 5 fractions if needed LNI 5 fractions
WBI 5 fractions
External beam radiotherapy in 5 fractions of 5,7Gy
LNI 5 fractions
External beam radiotherapy in 5 fractions of 5,4Gy
SIB 5 fractions if needed
Simultaneous boost of 5 x 6,2Gy (6,5Gy in case of involved resection margins) if needed
WBI with LNI - observational - 15
WBI 15 fractions SIB 15 fractions if needed LNI 15 fractions
WBI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
LNI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
SIB 15 fractions if needed
Simultaneous boost of 15x3,12Gy (3,33Gy in case of involved resection margins) if needed
thoracic wall irradiation (TWI) +/- LNI - observational - 5
TWI 5 fractions SIB 5 fractions if needed LNI 5 fractions
LNI 5 fractions
External beam radiotherapy in 5 fractions of 5,4Gy
TWI 5 fractions
External beam radiotherapy in 5 fractions of 5,7Gy
TWI +/- LNI - observational - 15
TWI 15 fractions SIB 15 fractions if needed LNI 15 fractions
LNI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
TWI 15 fractions
External beam radiotherapy in 15 fractions of 2,67Gy
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* multidisciplinary decision of adjuvant irradiation
* absence of distant metastases
* informed consent obtained, signed and dated before specific protocol procedures
Exclusion Criteria
* Bilateral breast irradiation
* Life expectancy of less than 2 years
* Planned reconstructive breast surgery
* Condition making toxicity evaluation difficult, e.g. skin disorders, pre-existing brachial plexus injury, …
* Inability to respect constraints on skin, heart, lungs, esophagus, ribs, brachial plexus or any other organ at risk
* Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
* Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits or unlikely to complete the study
65 Years
FEMALE
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Liv Veldeman, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Ghent University Hospital, Dept. Radiotherapy-Oncology
Locations
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Ghent University Hospital, Dept. Radiotherapy-Oncology
Ghent, , Belgium
Countries
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Related Links
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HAI-5 feasilibility trial: results acute toxicity
Other Identifiers
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EC/2016/1386
Identifier Type: -
Identifier Source: org_study_id