NCT01973634|CompletedPhase 2
Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery.
SeqB vs SIB
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SeqB vs SIB
Sponsor study identifier
interventional
170
1 country
1
Study Start
December 2012
Actual (reported)Primary Completion
December 2015
Actual (reported)Study Completion
March 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2012
Actual (reported)October 18, 2013
Actual (reported)October 31, 2013
Actual (reported)December 2015
Actual (reported)March 2021
Actual (reported)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.
Degree of acute skin toxicity.
Weekly during radiotherapy and 2 weeks after the end of radiotherapy.
Degree of chronic skin toxicity and cosmesis after radiotherapy.
2 weeks, 1 year, 2 years and 5 years after radiotherapy.
Quality of life after radiotherapy.
2 weeks, 1 year, 2 years and 5 years after radiotherapy.
Biomarker analysis.
Blood sample within 1 week before the start of radiotherapy
Measurement of costs for the patient for the full treatment.
Over the period of radiotherapy treatment, with a maximum of 5 weeks.
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 (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)
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 (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)
Ghent University Hospital
Ghent, 9000, Belgium
Wilfried De Neve, MD, PhD
University Hospital, Ghent
170 participants (actual enrollment reported by the registry).
First Submitted
October 18, 2013
First Posted
October 31, 2013
Study Start
December 2012
Actual (reported)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 (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)
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 (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)
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Primary Completion
December 2015
Actual (reported)Study Completion
March 2021
Actual (reported)Last Updated
December 2, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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