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Trial Title:
Proton Radiation Therapy for Invasive Breast Cancer Following Mastectomy
NCT ID:
NCT01340495
Condition:
Invasive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Mastectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Proton Radiation
Description:
45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for
approximately 5 1/2 weeks
Arm group label:
Proton Radiation
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Start date:
June 2011
Completion date:
January 2022
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01340495
