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Protocol No. A221505

Principal Investigator Anderson, Bethany

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction

Objective This study is being done to see if we can determine whether a short-course radiation therapy option (3 to 4 weeks) after mastectomy is as safe and effective in the setting of breast reconstruction as the usual 5 to 6 week treatment course. Short-course radiation therapy is also called hypofractionated radiation. This study will also examine whether a shorter course of radiation therapy will lower treatment costs and improve patient satisfaction.

  • Group 1 will get the usual 5 to 6 weeks radiation therapy used for this type of cancer.
  • Group 2 will get a shortened course with 3 to 4 weeks radiation therapy for this type of cancer
  • Breast reconstruction may happen before or after radiation as predetermined by your surgeon.

  • Description
  • Randomized trial testing the safety and patient experience of short course radiation after mastectomy and breast reconstruction for breast cancer

  • Key Eligibility
  • Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular). In-situ disease alone is not allowed
  • Final AJCC Stage IIa IIIa (pathologic stage T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status).
  • No prior radiation therapy to the chest, neck or axilla
  • No prior history of ipsilateral breast cancer (invasive disease or DCIS).
  • No history of prior or concurrent contralateral invasive breast cancer
  • No active collagen vascular diseases
  • No significant post mastectomy complications requiring an unplanned re-operation or admission for IV antibiotics.
  • Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
  • Radiation oncologist is NOT planning to utilize a chest wall/scar boost.
  • Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 8 months after radiation
  • Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
  • ECOG (Zubrod) Performance Status 0-1, Patient ≥ 18 years of age

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions Johnson Creek, UW Cancer Center; Swedish American Hospital, Rockford ; UW Hospital and Clinics