Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cance… (NCT02927912) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
United States, Canada108 participantsStarted 2017-10-16
Plain-language summary
This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.
Who can participate
Age range
18 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:
* Pathologically proven diagnosis of breast cancer
* Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer
* Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
* Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup
* History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry
* Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
* Absolute neutrophil count \> 1800 cells/cubic mm
* Platelets \>= 75,000 cells/cubic mm
* Hemoglobin \>= 8 g/dL
* Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry
* Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
* Patients must provide study specific informed consent prior to study entry
Exclusion Criteria:
* Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer
* Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry
* Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ \[LCIS\] is eligibl…
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
Number of Dose-limiting Adverse Events in the First 30 Patients Enrolled as Graded by the National Cancer Institute Common Toxicity Criteria Version 4.0
Timeframe: Up to 30 days after surgery and IOERT boost
2
Rate of Grade 3 Fibrosis Using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic Scales
Timeframe: At 1 year from the end of therapy
Trial details
NCT IDNCT02927912
SponsorOhio State University Comprehensive Cancer Center