Breast: Post-Mastectomy: Hypofractionated Radiotherapy: RT CHARM

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

Title
Alliance: A221505 \"RT Charm\"
Study Title

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

Site Link
Malignancy
Breast cancer
Stage
Disease Setting
Adjuvant: Curative
Line Of Therapy
Adjuvant
Investigational Agent
Hypofractionated radiotherapy
Drug Class
Radiation
PI
Noam VanderWalde, MD
Sponsor
Alliance for Clinical Trials in Oncology
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Invasive breast cancer (ductal, lobular, tubular, mammary, medullary)
  • If received neoadjuvant therapy, pre treatment staging must have N1 or N2 disease pre-chemo or are T3N0
  • If did not receive neoadjuvant, must be T0N1-2a, T1N1-2a, T2N1-2a, or T3N0-2a.
  • No prior therapeutic radiation to the chest, neck, or axilla
  • No prior history of ipsilateral breast cancer
    • DCIS or LCIS are allowed
  • Negative margins following mastectomy
  • No significant post mastectomy complications in the ipsilateral breast requiring unplanned re-operation or admission for IV antibiotics.
    • Reoperation for margins or lymph node dissection is allowed
  • Radiation oncologist is NOT planning to use a chest wall/scar boost
  • Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
  • No co-existing medical conditions with a life expectancy <5 years
  • ECOG PS 0-1
Objective
  • Primary
    • Rate of breast reconstruction complications
  • Secondary
    • Acute and late radiation complications
    • Local and regional recurrence
    • RFS
    • Arm lymphedema
    • Economic analyses
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Invasive ductal, invasive lobular, tubular
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X