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

Phase 2CompletedNCT01973634

University Hospital, Ghent170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Radiotherapy After Breast Conserving Surgery

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy.

Clinical inspection of the treated breast.

Time frame: weekly during radiotherapy, 2 weeks after the end of radiotherapy.

Secondary Outcomes

Degree of acute skin toxicity.

Clinical inspection.

Time frame: 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.

Time frame: 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.

Time frame: 2 weeks, 1 year, 2 years and 5 years after radiotherapy.

Biomarker analysis.

Blood sample

Time frame: Blood sample within 1 week before the start of radiotherapy

Measurement of costs for the patient for the full treatment.

Activity based costing models.

Time frame: Over the period of radiotherapy treatment, with a maximum of 5 weeks.