Upstate Active Clinical Trials Seeking Participants
Study title
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer (NSABP B-39 / RTOG 0413)
IRB number
16
What is the purpose of the study?
The purpose of this study is to determine whether partial breast irradiation is as good as or better than whole breast irradiation in keeping cancer from coming back in the breast.
Who is eligible?
(a) Stage 0, I, or II DCIS or invasive adenocarcinoma of the breast
(b) Subjects must have had a lumpectomy with margins free of tumor
(c) Subjects must have had only a single tumor, < 3 cm in size
(d) Subjects with invasive adenocarcinoma are required to have axillary staging (either sentinel biopsy alone and/or axillary dissection or sampling of a minimum of 6 axillary nodes)
(e) Subjects last surgery for breast cancer must be < 42 days prior to study entry
(f) Subjects must have estrogen receptor analysis performed on the primary tumor prior to study entry; progesterone receptor analysis is also desirable, but required only if the estrogen receptor status is negative
(g) The lumpectomy area to be treated must be clearly defined and < 30% of the entire breast
What is involved if I participate?
- How long is the study?
a) Subjects assigned to whole breast irradiation will receive 1 treatment a day, 5 days a week, for 5-7 weeks b) Subjects assigned to partial breast irradiation will receive 2 treatments a day (about 6 hours apart) on 5 days c) Subjects assigned to both treatments will be followed at 1, 6, & 12 months following treatment, every 6 months thereafter for 5 years, and yearly thereafter - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
Yes - What tests and procedures are involved?
Prior to Study Entry: a) history & physical exam b) chest x-ray or chest CT scan c) bone scan, bone x-rays, or bone tests (only if there is bone pain or if certain blood test results are not normal) d) CT scan of abdomen (only if blood tests related to liver function are abnormal) e) Mammogram f) breast exam g) CT scan of the breast that had the tumor (for radiation therapy planning) h) blood tests After the above tests have been completed, subjects will be randomized to receive either whole breast irradiation or partial breast irradiation. During the first year after breast irradiation has been completed: a) a brief history and physical exam at the end of radiation therapy, and about 1, 6, and 12 months after finishing radiation therapy, or after finishing radiation therapy and chemotherapy, if received b) a mammogram and breast examination will be performed at 6 months and 12 months after finishing radiation therapy, or after finishing radiation therapy and chemotherapy, if received During 2-5 years after entering the study, study subjects will have the following tests and procedures performed: a) a brief history and physical exam and breast examination will be performed every 6 months after finishing radiation therapy, or after finishing radiation therapy and chemotherapy, if received b) a mammogram will be performed every 12 months after finishing radiation therapy, or after finishing radiation therapy and chemotherapy, if received After the 5th year on the study, a brief history and physical exam, a mammogram, and an examination of subjects breasts will be required yearly.
Who is the doctor administering the study?
Hemangini Shah, DO
Where will the study take place?
University Hospital & Hill Radiation Oncology
Over what time period is the study scheduled to run?
March 2005 to on going.
Who can I contact for more information?
- Name: Dena Martin
- Phone: 315-464-5262
- Email: martind@upstate.edu
- Fax: 315-464-5943
Other information:
There are two optional additional studies in which subjects in this study can chose to take part.
a) Quality of Life and Cosmesis Study. The quality of life portion of this study looks at how the participants are feeling physically and emotionally during and after their cancer treatment and how well they are able to carry out their daily activities. The cosmesis portion of the study is being done to determine how satisfied participants are with the appearance of their breasts after surgery and radiation therapy. Subjects participating in this study will complete 7 questionnaires (one before receiving treatment, 3 during the first year, and the last 3 at 1, 2 & 3 years after completing radiation therapy). Subjects will also have photos taken of their breasts, so that the subjects opinions of the appearance of their breasts can be compared with the opinions of doctors who are experts in radiation therapy. These photos will include only the breasts; subjects faces will not be in the photos and names and other personal information will not be given out. The photos will be taken prior to radiation therapy and at 1 and 3 years after treatment is completed.
b) Use of Blood and Tissue for Future Research. In this study, participants are asked to allow the study sponsors to keep some of their blood and tissue samples for use in future research to learn more about cancer and other diseases. The requested tissue is some of that left over from the subjects original biopsies and from their lumpectomies. The requested blood consists of four tubes drawn prior to the subjects radiation therapy and then drawn again on one other occasion only if and when the subjects cancer reappears.
If you are interested in this trial, please contact the study coordinator or investigator noted above.
