Stanford APBI Trial
Clinical Trial
Overview
Intraoperative Radiotherapy (IORT) is one of three approaches used for accelerated, partial breast irradiation at Stanford.
Accelerated, partial breast irradiation (APBI) is a potentially important new way to incorporate radiotherapy in the treatment of women with breast cancer.
Currently, women with breast cancer who undergo a lumpectomy typically have 6 1/2 weeks of radiation to the entire affected breast after surgery. Accelerated, partial breast irradiation (APBI) changes this approach in two ways. It shortens the treatment time from 6 1/2 weeks to between 1 to 5 days, and reduces the treatment area from the entire breast to the area of the breast immediately around the lumpectomy site. This is the part of the breast where most cancers are likely to recur.
In many ways APBI is to current whole breast radiotherapy what a lumpectomy is to a mastectomy. The goal is to use a less invasive more focused treatment without compromising survival.
APBI has been used in limited trials in several hundred patients over the last 10 years. These trials show that in properly selected breast cancer patients APBI worked just as well as whole breast radiotherapy. In the initial studies, investigators relied on the placement of many catheters in the breast tissue (interstial brachytherapy). Newer techniques will hopefully provide the same good results but will deliver the radiation in faster and/or more convenient ways. This could increase interest in APBI and allow additional clinical trials that test the safety and effectiveness of the newer approaches. These newer approaches could increase quality of life for many women with breast cancer.
Investigators at Stanford University Medical Center are currently offering an IRB approved clinical trial that uses three new approaches for APBI. These three approaches are:
Intraoperative Radiotherapy (IORT) - 1 day
Intracavitary Brachytherapy (MammoSite) - 5 days
3-D Conformal/External Beam Radiotherapy - 5 days
The Stanford trial is led by Dr. Frederick Dirbas, Assistant Professor of Surgery, and by Dr. Donald Goffinet, Professor of Radiation Oncology. For further information about the trial please contact Janelle Maxwell or Triona Dolphin at (650) 498-7740.
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management.
The potential benefits and optimal timing of PCI in these patients are unknown. As TAVR expands to lower risk patients, and potentially becomes the preferred therapy for the majority of patients with severe aortic stenosis, the optimal management of concomitant coronary artery disease will be of increasing importance.
The COMPLETE TAVR study will determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving staged PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, new Myocardial Infarction, Ischemia-driven Revascularization or Hospitalization for Unstable Angina or Heart Failure.
The study will be a randomized, multicenter, open-label trial with blinded adjudication of outcomes. Patients will be screened and consented for elective transfemoral TAVR and randomized within 96 hours of successful balloon expandable TAVR.
Complete Revascularization:
Staged PCI using third generation drug eluting stents to treat all suitable coronary artery lesions in vessels that are at least 2.5 mm in diameter and that are amenable to treatment with PCI and have a ≥70% visual angiographic diameter stenosis. Staged PCI can occur any time from 1 to 45 days post successful transfemoral TAVR.
Vs. Medical Therapy Alone:
No further revascularization of coronary artery lesions.
All patients, regardless of randomized treatment allocation, will receive guideline-directed medical therapy consisting of risk factor modification and use of evidence-based therapies. The COMPLETE TAVR study will help address the current lack of evidence in this area. It will likely impact both the global delivery of health care and the management and clinical outcomes of all patients undergoing TAVR with concomitant CAD.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: Percutaneous Coronary Intervention (PCI)
Eligibility
Inclusion Criteria:
- Symptomatic aortic valve stenosis prior to TAVR (NYHA Functional Class ≥ 2 OR Abnormal
exercise test with severe SOB, abnormal BP response, or arrhythmia)
AND
- CAD defined as: at least 1 coronary artery lesion of ≥70% visual angiographic diameter
stenosis in a native segment ≥2.5 mm in diameter that is not a CTO and is amenable to
treatment with PCI
AND
- Consensus by the Local Multidisciplinary Heart Team that the patient is suitable for
elective transfemoral TAVR with a balloon expandable transcatheter heart valve AND would
receive a bypass with an anastomosis distal to the coronary artery lesion(s) if they were
undergoing SAVR.
Local Multidisciplinary Heart Teams are expected to follow current clinical guidelines for
selection of patients for TAVR with an eligible patient generally expected to have:
[AVA ≤ 1.0 cm2 OR AVA index ≤ 0.6 cm2/m2]
OR
[Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg]
OR
patients without these criteria may undergo TAVR if the Local Multidisciplinary Heart Team
concludes it is appropriate.
AND
- Successful transfemoral TAVR, defined as the implantation of a single transcatheter
aortic valve within the past 96 hours with freedom from more than minimal aortic
insufficiency, stroke, or major vascular complications.
Exclusion Criteria:
- PCI already performed within 90 days prior to TAVR or at the same time as the index
transfemoral TAVR procedure
- Planned PCI of coronary artery lesion(s)
- Planned surgical revascularization of coronary artery lesion(s)
- Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
- Any factor precluding 5-year follow-up
- Prior coronary artery bypass grafting surgery or surgical valve replacement
- Severe mitral regurgitation (> 3+)
- Severe left ventricular dysfunction (LVEF < 30%)
- Low coronary takeoff (high risk for coronary obstruction)
- Acute myocardial infarction within 90 days
- Stroke or transient ischemic attack within 90 days
- Renal insufficiency (eGFR < 30 ml/min) and/or renal replacement Rx
- Hemodynamic or respiratory instability
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting
What's New
Stanford’s APBI trial has now been expanded to include women with ductal carcinoma in situ (DCIS). Please call 650-498-7740 for more information.