Clinical trial NCT01973634: Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery.
Official title: Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radiotherapy After Breast Conserving Surgery
Keywords: Radiotherapy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy.
timeFrame: weekly during radiotherapy, 2 weeks after the end of radiotherapy.
Secondary outcomes:
measure: Degree of acute skin toxicity.
timeFrame: Weekly during radiotherapy and 2 weeks after the end of radiotherapy.
measure: Degree of chronic skin toxicity and cosmesis after radiotherapy.
timeFrame: 2 weeks, 1 year, 2 years and 5 years after radiotherapy.
measure: Quality of life after radiotherapy.
timeFrame: 2 weeks, 1 year, 2 years and 5 years after radiotherapy.
measure: Biomarker analysis.
timeFrame: Blood sample within 1 week before the start of radiotherapy
measure: Measurement of costs for the patient for the full treatment.
timeFrame: Over the period of radiotherapy treatment, with a maximum of 5 weeks.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: