An observational study in Early-stage Breast Cancer, Breast Carcinoma in Situ and Breast Neoplasms, sponsored by Saint John's Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Saint John's Cancer Institute · Observational
This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.
At Providence Saint John's Health Center, there is the ongoing integration of Intra-Operative Radiation Therapy (IORT) as a standard treatment option among Breast Conserving Therapy (BCT) for individuals with in situ and early stage breast cancer. Currently, approximately 60 women per year are being treated with IORT. No repository of information of patient outcomes with this treatment has been established. This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT.
As the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint John's Health Center, this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy. In addition, the Providence Health \& Services strives to improve patient care and outcomes with excellence whenever possible. The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Saint John's Cancer Institute is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Any individual aged ≥ 18 years with early stage breast cancer who is determined to be suitable candidates for breast-conserving surgery and IORT by a multidisciplinary team.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All participants who plan to undergo partial mastectomy for treatment of early stage breast cancer will be considered for eligibility for IORT. Patient with single breast cancer less than 3cm in disease span, clinical negative axillary node will be offered the option of having IORT. If IORT is delivered following surgical resection of the tumor they will be followed in this registry for short and long term outcomes.
Radiation: Intraoperative Radiation Therapy (IORT)
IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery
Disease Recurrence
Presence of recurrent tumor in ipsilateral breast or distant site
Time frame: 5 years
Disease specific survival
survival
Time frame: 10 years
Overall Survival
survival
Time frame: 10 years
Started Oct 2018 (actual). Primary completion is estimated for Oct 2028, 120 months after the start.
Of 1,012 non-industry observational studies under Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's planned 120 months is above that.
Counting every sponsor, half of 1,165 studies reached it within 58 months; a quarter within 26 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
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Saint John's Cancer Institute