Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conser… (NCT01570998) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
United States1,259 participantsStarted 2012-05-18
Plain-language summary
This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.
Who can participate
Age range
45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Suitable for breast conserving surgery
* T1 and T2 (\< 3.5 cm), N0, M0
Exclusion Criteria:
* Axillary lymph node positive breast cancer
* Tumor size \> 3.5 cm
* Extensive intraductal component (EIC \>= 25% of the lumpectomy specimen involved with ductal carcinoma in situ), as assessed on surgical pathologic lumpectomy specimen
* Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
* Inability to assess pathologic margin status
* Synchronous bilateral breast cancer at the time of diagnosis
* Ipsilateral breast had a previous cancer and/or prior in-field radiation
* Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required)
* Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size
* Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater
* Any factor included as exclusion criteria in the participating center's treatment policy statement
* Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy):
* Patients under the age of 50
* Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
* Human epidermal growth fac…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of local recurrence
Timeframe: Up to 5 years
2
Frequency of site of relapse within the breast
Timeframe: Up to 5 years
3
Percentage of participants with treatment-related adverse events