Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial)
Summary
The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.
Arms & interventions
- RadiationIntensity modulated radiation therapy (IMRT)
40 Gy total in 15 consecutive weekday sessions to the partial breast
Outcome measures
Primary
Rate of grade 3 or higher treatment-related adverse events (AEs)
Adverse events will be collected using Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) starting from the first radiation treatment. Grade 1 AEs are considered mild, grade 2 AEs are considered moderate, grade 3 AEs are considered severe, grade 4 AEs are considered life-threatening, and grade 5 AEs are considered fatal. The percentage of participants experiencing grade 3 or higher treatment-related AEs will be calculated.
Time frame: 1 year
Secondary
Local recurrence-free survival (LRFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Distant metastasis-free survival (DMFS)
Time frame: 5 years
Mastectomy-free survival (MFS)
Time frame: 5 years
Change in patient-rated cosmesis
Time frame: Over 5 years
Eligibility criteria
Study locations (2)
Lynn Cancer Institute at Baptist Health, Inc.
Boca Raton, Florida, 33486
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
References
- Arthur DW, Winter KA, Kuerer HM, Haffty B, Cuttino L, Todor DA, Anne PR, Anderson P, Woodward WA, McCormick B, Cheston S, Sahijdak WM, Canaday D, Brown DR, Currey A, Fisher CM, Jagsi R, Moughan J, White JR. Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320.(PubMed)
- Arthur DW, Winter KA, Kuerer HM, Haffty BG, Cuttino LW, Todor DA, Simone NL, Hayes SB, Woodward WA, McCormick B, Cohen RJ, Sahijdak WM, Canaday DJ, Brown DR, Currey AD, Fisher CM, Jagsi R, White J. NRG Oncology-Radiation Therapy Oncology Group Study 1014: 1-Year Toxicity Report From a Phase 2 Study of Repeat Breast-Preserving Surgery and 3-Dimensional Conformal Partial-Breast Reirradiation for In-Breast Recurrence. Int J Radiat Oncol Biol Phys. 2017 Aug 1;98(5):1028-1035. doi: 10.1016/j.ijrobp.2017.03.016. Epub 2017 Mar 18.(PubMed)
- Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.(PubMed)