Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery.

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2021-03-31

Brief Summary

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Whole breast irradiation (WBI) after breast conserving surgery for early-stage breast cancer halves the recurrence risk and reduces the breast cancer death by about one sixth. A sequential boost (SeqB) dose to the tumour bed further improves local control, but also increases the risk of late skin toxicity and cosmetic changes. At Ghent University Hospital WBI is prescribed in 15 fractions of 2.67 Gy according to the START-B hypofractionation scheme. A sequential boost is typically given in 4 to 8 extra fractions which prolongs the overall treatment time. The boost dose can also be delivered within the 15 fractions of WBI, the so-called simultaneous integrated boost (SIB). SIB shortens the overall treatment time which is convenient for the patient and the radiotherapy department. In this study we wish to test the hypothesis of acceptable skin toxicity and reduced cost with SIB using hypofractionated prone intensity modulation radiotherapy IMRT with topographical dose painting, a technique recently developed in our group. Patients are randomized between SeqB and SIB.

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Detailed Description

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Conditions

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Radiotherapy After Breast Conserving Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Minimal surgical margin 1 mm, conventional arm: seq boost

Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost).

Group Type ACTIVE_COMPARATOR

sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)

Intervention Type RADIATION

Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)

Minimal surgical margin of 1 mm, experimental arm with SIB

Minimal surgical margin of 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)

Group Type EXPERIMENTAL

SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)

Intervention Type RADIATION

Minimal surgical margin of 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)

Minimal surgical margin <1 mm, conventional arm: seq boost

Minimal surgical margin \< 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)

Group Type ACTIVE_COMPARATOR

sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)

Intervention Type RADIATION

Minimal surgical margin \< 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)

Minimal surgical margin < 1 mm, experimental arm with SIB.

Minimal surgical margin \< 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)

Group Type EXPERIMENTAL

SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)

Intervention Type RADIATION

Minimal surgical margin \< 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)

Interventions

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sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)

Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)

Intervention Type RADIATION

SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)

Minimal surgical margin of 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)

Intervention Type RADIATION

sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)

Minimal surgical margin \< 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)

Intervention Type RADIATION

SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)

Minimal surgical margin \< 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

Female patients AND breast conserving surgery AND multidisciplinary decision of adjuvant WBI with a boost to the tumor bed AND age ≥ 18 years AND informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria

* Mastectomy
* Need for lymph node irradiation
* No boost
* Bilateral breast irradiation
* Patient not able to reach or maintain the prone position
* Pregnant or breastfeeding
* 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, and unlikely to complete the study

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No