Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:June 2011
End Date:January 2022

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Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy

In this study we are looking at a type of radiation called proton radiation which is known to
spare surrounding tissue and organs from radiation. The proton radiation will be delivered
using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton
Radiation Treatment). Proton radiation delivers no dose beyond the region requiring
treatment. This may reduce side effects that patients would normally experience with
conventional radiation therapy or other means of delivering proton radiation therapy. In this
study we are evaluating the effectiveness of using proton radiation delivered to reduce side
effects association with radiation treatment.

Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be
assessed weekly for any side effects they may be experiencing.

Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12
months, and then every year for up to five years after treatment. Follow-up visits will
include a physical examination, radiological imaging (if necessary), echocardiogram, and
laboratory tests.

Inclusion Criteria:

- Histologically confirmed invasive breast cancer confined to the breast and regional
lymphatics

- Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery

- Life expectancy > 12 months

Exclusion Criteria:

- Pregnant or breast-feeding

- Prior therapeutic radiation > 200 cGy

- History of a different malignancy unless disease-free for at least 5 years or
diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the
skin

- Prior investigation chemotherapy
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Shannon M MacDonald, MD
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mi
from
Boston, MA
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