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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimal surgical margin 1 mm, conventional arm: seq boost | Active Comparator | Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost). |
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| Minimal surgical margin of 1 mm, experimental arm with SIB | Experimental | 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) |
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| Minimal surgical margin <1 mm, conventional arm: seq boost | Active Comparator | Minimal surgical margin < 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost) |
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| Minimal surgical margin < 1 mm, experimental arm with SIB. | Experimental | Minimal surgical margin < 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost) | Radiation | Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost) |
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy. | Clinical inspection of the treated breast. | weekly during radiotherapy, 2 weeks after the end of radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of acute skin toxicity. | Clinical inspection. | Weekly during radiotherapy and 2 weeks after the end of radiotherapy. |
| Degree of chronic skin toxicity and cosmesis after radiotherapy. | Inspection, clinical evaluation, digital photographs. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried De Neve, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Related Info | View source |
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| SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy) | 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) |
|
| sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost) | Radiation | Minimal surgical margin < 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost) |
|
| SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy) | 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) |
|
| 2 weeks, 1 year, 2 years and 5 years after radiotherapy. |
| Quality of life after radiotherapy. | QLQ C30 and QLQ BR23 quality of life questionnaires. | 2 weeks, 1 year, 2 years and 5 years after radiotherapy. |
| Biomarker analysis. | Blood sample | Blood sample within 1 week before the start of radiotherapy |
| Measurement of costs for the patient for the full treatment. | Activity based costing models. | Over the period of radiotherapy treatment, with a maximum of 5 weeks. |