Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer (NCT04088435) | Clinical Trial Compass
TerminatedNot Applicable
Xoft® Intraoperative Radiotherapy (IORT) for Patients With Early-Stage Breast Cancer
Stopped: Low accrual
United States10 participantsStarted 2019-09-10
Plain-language summary
Intraoperative radiotherapy (IORT) is a type of accelerated partial breast irradiation (APBI) in which radiation therapy is delivered to the breast tissue in a single treatment at the time of lumpectomy for breast cancer. The Xoft device (Axxent, Xoft, San Jose, CA) is a device that allows for IORT for breast cancer using kilovoltage (kV) photons. A central goal of this study is to report acute and late toxicities and cosmetic outcomes following breast IORT with the Xoft device in women with early-stage breast cancer treated with lumpectomy. The investigators hypothesize that IORT following lumpectomy will be safe and well tolerated with a lower rate of physician reported acute side effects than traditional whole breast radiation therapy after lumpectomy.
Who can participate
Age range
50 Years
Sex
ALL
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:
* T1 or T2 invasive carcinoma of the breast undergoing breast conserving surgery
* Clinically lymph node negative and Memorial Sloan Kettering nomogram estimates 20% or less risk of positive sentinel node
* Tumors 2.5 cm or less in size (clinical preoperative staging)
* Estrogen receptor positive tumors (≥10%)
* Her2 negative/not over-expressed
* Patients 50 years of age or greater
Exclusion Criteria:
* Prior malignancy not in remission
* Active collagen vascular disease requiring active cytotoxic or immunotherapy
* Psychiatric or mental condition which would preclude informed consent
* Prior thoracic radiation which overlaps with IORT field
* Pregnant patients
* Patients \<50 years
* Risk of positive sentinel lymph node \>20% based on nomogram estimates
* Known lymph node metastases (i.e. clinically node positive)
* Patients with invasive lobular carcinoma
* Patients with pure DCIS
* Known multifocal or multicentric tumor
* Patients requiring neoadjuvant chemotherapy
* Patients requiring or choosing mastectomy with or without reconstruction
* Technical contraindications to IORT dose delivery including skin to balloon distance \<7 mm
* Medical contraindication to IORT, radiation or breast conservation
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
Percentage of patients with greater than or equal to grade 2 acute radiation toxicities