Stanford APBI Trial
Clinical Trial
Overview
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.
Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea
This trial is conducted in North America. The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: liraglutide
- drug: placebo
Eligibility
Inclusion Criteria:
- Informed consent
- Body mass index equal to or above 30 kg/m^2
- Stable body weight (less than 5% self-reported change during the previous 3 months)
- Diagnosis of moderate or severe obstructive sleep apnoea (OSA)
- Unwilling or unable to use continuous positive airway pressure (CPAP) (or other
positive airway pressure) treatment. No CPAP (or other positive airway pressure)
treatment for at least four weeks prior to screening
- Ability and willingness to comply with all protocol procedures e.g. correct handling
of trial product, compliance to visit schedule and dietary advice and complete trial
related questionnaires
Exclusion Criteria:
- Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl
peptidase-4 inhibitors or insulin within the last 3 months prior to screening
- Diagnosis of type 1 or type 2 diabetes per judgement of the investigator
- Glycosylated haemoglobin (HbA1c) equal to or above 6.5%
- Significant craniofacial abnormalities that may cause OSA
- Respiratory and neuromuscular diseases that could interfere with the results of the
trial in the opinion of the investigator
- Use of central stimulants, hypnotics, mirtazepine, opioids, trazodone within the
previous 3 months prior to screening
- Obesity induced by drug treatment
- Treatment with pramlintide, sibutramine, orlistat, zonisamide, topiramate or
phenteremine within the last 3 month prior to screening
- Previous surgical treatment for obesity
- Screening calcitonin equal to or above 50 ng/L
- Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial
Medullary Thyroid Carcinoma
- Personal history of non-familial Medullary Thyroid Carcinoma
- History of chronic pancreatitis or idiopathic acute pancreatitis
- History of Major Depressive Disorder or suicide attempts
- Systolic blood pressure equal to or above 160 mmHg and/or diastolic blood pressure
equal to or above 100 mmHg
Ages Eligible for Study
18 Years - 64 Years
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.