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Protocol No. A221505
Principal Investigator Anderson, Bethany
Age Group Adult
Sponsor Type National
Title 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
Breast reconstruction may happen before or after radiation as predetermined by your surgeon.
Randomized trial testing the safety and patient experience of short course radiation after mastectomy and breast reconstruction for breast cancer
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
Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Johnson Creek, UW Cancer Center; Swedish American Hospital, Rockford ; UW Hospital and Clinics