Hypofractionated Radiotherapy After Breast Conserving Surgery

  • STATUS
    Recruiting
  • participants needed
    82
  • sponsor
    Mayo Clinic
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Updated on 8 November 2020
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adjuvant chemotherapy
breast-conserving surgery

Summary

The optimal dose and fractionation regimen for whole breast irradiation, whole breast and regional nodal irradiation, and postmastectomy radiotherapy remains unknown. The goal of this phase II randomized controlled trial is to determine whether the hypofractionated proton regimens proposed are non-inferior compared with standard fractionated proton radiotherapy and therefore worthy of further investigation.

Description

Primary Objectives

To determine the 24-month complication rate of 25Gy in 5 fractions whole radiotherapy +/- concurrent boost as compared to 40Gy in 15 fraction radiotherapy +/- sequential boost. Complications will be defined as one or more of the following events: 1) grade 3 or higher late adverse event, 2) deterioration of cosmesis from excellent/good to fair/poor or from fair to poor.

ARM 1: Conventional hypofractionation 40 Gy (RBE) / Gy in 15 daily fractions with optional 10 Gy (RBE) / Gy in 4 fractions sequential boost to a total dose of 50 Gy in 19 fractions; or a concomitant boost to total dose of 48Gy in 15 daily fractions.(n=41)

ARM 2: 5 Fraction Hypofractionation 25 Gy (RBE) / Gy in 5 daily fractions with optional concurrent boost to a total dose of 30 Gy (RBE) / Gy in 5 fractions (n=41)

Details
Condition Breast Cancer
Treatment hypofractionation
Clinical Study IdentifierNCT03339934
SponsorMayo Clinic
Last Modified on8 November 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histological confirmation of breast cancer
Pathologic Stage T0-T3N0-N1M0
ECOG Performance Status (PS) 0 to 2. (Appendix I)
Able to and provides IRB approved study specific written informed consent
Study entry must be within 12 weeks of last surgery (breast or axilla) or last chemotherapy (if applicable)
Able to complete all mandatory tests listed in section 4.0
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Fair, good or excellent cosmesis, as determined by trained nurse assessment using the Harvard Cosmetic Scale
Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last dose of adjuvant chemotherapy
Breast conserving surgery and indications for whole breast radiotherapy

Exclusion Criteria

Medical contraindication to receipt of radiotherapy
Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent
Active systemic lupus or scleroderma
Pregnancy
Prior receipt of ipsilateral breast or chest wall radiation
Positive margins on ink after definitive surgery either for DCIS or invasive cancer
History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entry
Recurrent breast cancer
Indications for comprehensive regional nodal irradiation
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