A Phase III Study Comparing Short-Course with Conventional Radiation Therapy in Women Having Mastectomy and Breast Reconstruction for Breast Cancer

Full Title

RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction (A221505) (CIRB)

Purpose

Some women receive radiation therapy after a mastectomy to reduce the chance that the breast cancer will come back. Conventional radiation therapy takes five to six weeks. “Hypofractionated” radiation therapy consists of slightly higher doses of radiation given over a shorter period of three to four weeks, with the total dose after all treatments being slightly lower than conventional radiation therapy.

In this study, researchers want to compare the effectiveness of the short-course radiation treatment with conventional radiation in women having a mastectomy and breast reconstruction. Women in this study will be randomly assigned to one radiation therapy regimen or the other. Reconstruction may be performed at the time of mastectomy or at a later date.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage I-III breast cancer with treatment that includes mastectomy and radiation therapy.
  • Patients may not have a prior history of breast cancer in either breast (including ductal carcinoma in situ).
  • Patients may not have had prior radiation therapy to the chest.
  • Patients must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 18 months after radiation therapy is completed.
  • For patients who have an expander in the breast at the time of radiation, it must be fluid-filled (not air-filled).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Atif Khan at 848-225-6334.

Protocol

18-476

Phase

III

Investigator

Diseases