Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery.
- Conditions
- Radiotherapy After Breast Conserving Surgery
- Interventions
- Radiation: SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)Radiation: sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)Radiation: SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)Radiation: sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)
- Registration Number
- NCT01973634
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 170
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Minimal surgical margin of 1 mm, experimental arm with SIB 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) Minimal surgical margin 1 mm, conventional arm: seq boost 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). Minimal surgical margin < 1 mm, experimental arm with SIB. 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) Minimal surgical margin <1 mm, conventional arm: seq boost 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)
- Primary Outcome Measures
Name Time Method Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy. weekly during radiotherapy, 2 weeks after the end of radiotherapy. Clinical inspection of the treated breast.
- Secondary Outcome Measures
Name Time Method Degree of acute skin toxicity. Weekly during radiotherapy and 2 weeks after the end of radiotherapy. Clinical inspection.
Measurement of costs for the patient for the full treatment. Over the period of radiotherapy treatment, with a maximum of 5 weeks. Activity based costing models.
Degree of chronic skin toxicity and cosmesis after radiotherapy. 2 weeks, 1 year, 2 years and 5 years after radiotherapy. Inspection, clinical evaluation, digital photographs.
Quality of life after radiotherapy. 2 weeks, 1 year, 2 years and 5 years after radiotherapy. QLQ C30 and QLQ BR23 quality of life questionnaires.
Biomarker analysis. Blood sample within 1 week before the start of radiotherapy Blood sample
Trial Locations
- Locations (1)
Ghent University Hospital
🇧🇪Ghent, Belgium