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.
Blood Pressure Lowering in Acute Stroke Trial (BLAST)
Patients who are suffering from a stroke often present to the hospital with elevated blood pressure. Elevated blood pressure in the setting of stroke increases the risk of brain swelling or bleeding into the brain. Even so, there has been concern about lowering the blood pressure with medications because the newly injured parts of the brain may not get the blood flow they need, thereby worsening the damage from the initial stroke. We hope to demonstrate that the drug valsartan can be used safely and modestly to lower blood pressure in acute stroke patients, without having a detrimental effect on brain blood flow or neurologic status. Novel MRI techniques to measure brain blood flow will be used in conjunction with clinical scales to demonstrate safety.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Valsartan
- drug: Valsartan
Eligibility
Inclusion Criteria:
1. Men and non-pregnant women over age 18 who have had an acute ischemic stroke referable
to the anterior circulation, as diagnosed by one of more of the following: clinical
judgment, head CT, and/or MR imaging [i.e. a positive diffusion-weighted imaging (DWI)
abnormality].
2. Clinical syndrome not likely to represent transient ischemic attack (TIA) or other
non-stroke etiology
3. Patient must be neurologically stable at the time of first MRI scan (i.e. stable NIH
Stroke Scale score).
4. Initial MRI scan obtainable within 48 hours of symptom onset.
5. A pre-existing diagnosis of hypertension, either treated or untreated.
6. Average of two mean arterial blood pressures (separated by at least five minutes) at
time of enrollment.
Exclusion Criteria:
1. Patients who have taken an angiotensin-converting enzyme (ACE) inhibitor or
angiotensin receptor blocker (ARB) within seven (7) days of admission.
2. Patients who received intravenous or intra-arterial r-TPA for their current symptoms,
or those who underwent mechanical thrombolysis.
3. Patients with hemorrhagic strokes, as seen on the initial head CT.
4. Patients with stroke-like symptoms, but no demonstrable lesion on DWI, or a DWI lesion
< 2 cm in diameter (greatest dimension).
5. Patients with high-grade (>70%) internal carotid artery stenosis or occlusion
ipsilateral to the current stroke.
6. Patients with high-grade aortic or mitral stenosis.
7. Patients with a previous adverse reaction to valsartan or other ARBs.
8. Patients with contraindications for MRI, including pacemakers, claustrophobia, or
severe obesity.
9. Patients who are medically unstable for MR imaging, as determined by the treating
team.
10. Patients with a severe co-existing disease that may interfere with the conduct of the
study.
11. Patients receiving investigational drug therapies.
12. Informed consent cannot be obtained from the patient or an appropriate surrogate.
Ages Eligible for Study
18 Years - 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.