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Clinical Trial Summary

The goal of this clinical research study is to find out if receiving a 1-week course of partial breast irradiation (PBI) using proton therapy will cause fewer and/or less severe side effects (such as changes to the appearance of the breast) than a longer course of radiation treatment.

This is an investigational study. Proton radiation therapy is FDA approved and commercially available for breast cancer. Up to 200 women will take part in the study. All will be enrolled at MD Anderson.

Clinical Trial Description

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 10 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 4-10. 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 10 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT01245712
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Eric A. Strom, MD, BS
Phone 713-563-2300
Status Recruiting
Phase Phase 2
Start date November 15, 2010
Completion date November 1, 2022

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