Hypofractionated Radiotherapy After Breast Conserving Surgery

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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.
  • Women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
  • 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.
  • Male subjects.
  • Patient requires bilateral breast radiation treatment.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kimberly Corbin, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Carlos Vargas, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Laura Vallow, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20379666

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