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

  • STATUS
    Recruiting
  • participants needed
    170
  • sponsor
    University Hospital, Ghent
Updated on 8 November 2020

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.

Details
Condition Early Breast Cancer Patients Needing Radiotherapy After Breast Conserving Surgery.
Treatment sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost), 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), SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)
Clinical Study IdentifierNCT01973634
SponsorUniversity Hospital, Ghent
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Early Breast Cancer Patients Needing Radiotherapy After Breast Conserving Surgery.?
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
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