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Alliance A221505

Status:

Recruiting | Phase III

Official Title:

Phase III Randomized Trial of Hypo-fractionated Post Mastectomy Radiation with Breast Reconstruction

Study Purpose:

To determine if a shorter course of radiation therapy (3-4 weeks) is as safe and effective as the typical 5 to 6 week treatment course after mastectomy.

Interventions:

  • Radiation Therapy
  • Group 1: 5-6 weeks of radiation therapy (usual approach)
  • Group 2: 3-4 weeks of hypofractionated radiation therapy
  • Quality of Life Questionnaires

All patients enrolled on this trial will receive radiation after mastectomy.  All patients will also have breast reconstruction.  The reconstruction can be done at the time of the mastectomy before enrollment to the study, or as a separate surgery later.  

The study doctor will continue to watch for side effects and follow your condition for 5 years after the completion of radiation therapy.

Key Participation Requirements:

Gender:

Female

Age:

19 years and older

Diagnosis:

Invasive Cancer of the Breast

Eligibility:

Planned radiation and re-construction after mastectomy

No prior radiation therapy

No prior history of breast cancer

No other cancers within 5 years prior to registration on this study

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

A221505

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!