Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation
PBI is radiation therapy given only to the area of the breast where the cancer was removed.
The study staff will use proton-beam radiation to deliver the radiation therapy dose in a
more targeted way than other types of radiation, so that less of the healthy tissue is
affected.
Proton-Beam PBI Treatment:
If you take part in this study, you will have proton radiation therapy delivered to the area
of the lumpectomy 2 times per day, at least 6 hours apart, for 5 (or rarely 6) working days
in a row. You will be placed in a cradle and the beam is aimed at the area of interest. You
will not feel anything when the treatment is being delivered. The treatment lasts only a
few minutes, but you may be in the treatment room longer because the radiation therapists
will need to make sure that you are positioned correctly and that the beam is aimed at the
correct area. The study staff will show you a video that helps to explain this process.
Although you will need to be at the proton radiation center 2 times a day for your radiation
therapy, you are free to leave the proton radiation center between the 2 treatments, and you
should be able to do routine daily activities between treatments. This type of radiation
does not stay in your body between treatments or after the final treatment.
End-of-Treatment Tests:
On the last (or next-to-last) day of proton-beam PBI, you will have the following tests
performed:
- Your medical history will be recorded, and you will be asked about any side effects you
have had.
- You will have a physical exam.
- You and your doctor will each fill out the questionnaire about breast changes.
- Photographs will be taken of your breasts to check the appearance of the treated breast
after radiation.
At the end of radiation treatment, you will be asked how much personal time was used and how
much personal money you spent during treatment. This will only take a few minutes to
complete.
Length of Study:
You will receive 5 weekdays of radiation.
Your participation on the study will be over once you have completed the follow-up visits.
Follow-up Tests:
You are being asked to return to the clinic for follow-up testing for up to a total of 5
years. During the first year, there are 4 follow-up visits: about 2 weeks after treatment,
about 6 weeks after treatment, about 6 months after treatment, and about 1 year after
treatment. During the second and third year, you will come to the clinic every 6 months, and
once a year after that for Years 4 and 5. Some of these visits may be completed by phone
call or email.
During these follow-up visits, the following procedures will occur:
- Your medical history will be recorded, and you will be asked about any side effects you
have had.
- You will have a physical exam.
- You and your doctor will each fill out the questionnaire about breast changes. This
will only take a few minutes to complete.
- Photographs will be taken of your breasts to check the appearance of the treated breast
after radiation.
You will have a mammogram 6 months after treatment, 1 year after treatment, and then once a
year after that for up to 5 years (as part of this study). You should continue having
mammograms once a year after that, as part of your normal medical follow-up and health
screening.
This is an investigational study. Proton radiation therapy is FDA approved and commercially
available for breast cancer. Up to 100 women will take part in the study. All will be
enrolled at MD Anderson.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient-Reported Cosmesis Score
Patient-reported cosmesis score on the Breast Cancer Treatment Outcomes Scale (BCTOS) at 1 year. Cosmesis scores range from 1 (excellent) to 4 (poor), and scores of 3 (fair) or more indicate adverse cosmetic outcomes.
1 year
No
Eric A. Strom, MD, BS
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2009-0818
NCT01245712
November 2010
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |