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.
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral circulation will be assigned to either the Penumbra System with the Separator 3D or the Penumbra System without the Separator 3D. Each treated patient will be followed and assessed for 3 months after randomization. Up to 230 evaluable patients at up to 50 centers presenting with acute ischemic stroke in vessels accessible to the Penumbra Separator 3D System for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion is not inferior to the Penumbra System alone.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: Penumbra System with Separator 3D
- device: Penumbra System alone
Eligibility
Inclusion Criteria:
- From 18 to 85 years of age
- Present with symptoms consistent with an acute ischemic stroke for revascularization
within 8 hours from symptom onset
- Refractory to or not eligible for IV rtPA therapy., e.g., presenting between 0 and 3
hours from symptom onset AND contraindicated for IV rtPA, or presenting between 3 and
8 hours of symptom onset, or evidence of persistent occlusion from vascular imaging
after IV rtPA
- Evidence of a large vessel (2.5mm or greater in diameter) occlusion in the cerebral
circulation
- NIH Stroke Scale (NIHSS) score 8 or more points
- Signed informed consent
Exclusion Criteria:
- History of stroke in the past 3 months.
- Females who are pregnant
- Pre-existing neurological or psychiatric disease that could confound the study results
such as a pre-stroke mRS score 1 or higher
- Known severe allergy to contrast media
- Uncontrolled hypertension (defined as systolic blood pressure >185 mmHg or diastolic
blood pressure >110 mmHg)
- CT evidence of the following conditions at randomization:
- Significant mass effect with midline shift
- Large infarct region >1/3 of the middle cerebral artery territory
- Evidence of intracranial hemorrhage
- Angiographic evidence of an arterial stenosis proximal to the occlusion that could
prevent thrombus removal
- Angiographic evidence of preexisting arterial injury
- Rapidly improving neurological status prior to enrollment
- Bilateral stroke
- Intracranial tumors
- Known history of cerebral aneurysm or arteriovenous malformation
- Known hemorrhagic diathesis, coagulation deficiency, or on anticoagulant therapy with
an International Normalized Ratio (INR) of >1.7
- Baseline platelets <50,000
- Use of IV heparin in the past 48 hours with PTT >1.5 times the normalized ratio
- Baseline glucose <50mg/dL or >300mg/dL
- Life expectancy less than 90 days prior to stroke onset
- Participation in another clinical investigation that could confound the evaluation of
the study device
Ages Eligible for Study
18 Years - 85 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Stephanie Kemp
(650) 723-4481
I'm interested
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.