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.
Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss
The goal is to determine if improved sleep will increase/enhance weight loss among overweight adults with insomnia.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- behavioral: Diet and exercise
- behavioral: Cognitive Behavioral Therapy
- behavioral: Passion and Balance
Eligibility
Inclusion Criteria:
- Gender: Both women and men
- Age: > or = 18 years
- Ethnicity and race: All ethnic and racial backgrounds welcome
- The following, which will be measured at the screening clinic visit:
- Body Mass Index: 28-40 (kg/m-squared)
- Chronic Short Sleep: total sleep time < 6.5 hours, greater than or equal to 4
days per week (determined by 1-week sleep log) for the past 6 months or longer
(based on self-report).
- Insomnia: sleep latency and/or wake after sleep onset > 30 minutes, greater than
or equal to 4 days per week, insomnia severity index > 10, and complaint of at
least one negative effect during waking hours (such as fatigue, sleepiness,
impaired functioning, mood disturbance) attributed to sleep (as determined by
self report).
- Eligible sleep disorder: sleep apnea or upper airway resistance syndrome treated
by positive airway therapy for > or = 3 months resulting in improved sleep.
- Psychiatric disorders that are stable on SSRI, SNRI, or bupropion antidepressant
for greater than or equal to 3 months if no anticipated changes in medications to
occur during the trial if they are weight stable.
- Planning to be available for clinic visits and for the 8 weeks of study
participation
- Ability and willingness to give written informed consent.
Exclusion Criteria:At screening:
- Sleep apnea (apnea-hypopnea index > 15/hr) determined by portable sleep diagnostic
system Periodic limb movements during sleep (PLM with arousal index > 15/hr)
determined by polysomnography.
- Any suspected sleep disorders identified by the Global Sleep Assessment Questionnaire,
including circadian rhythm disorders (including shift work), parasomnias, narcolepsy,
and restless leg.
- Self reported personal history of:
- DSM-IV Axis-I and Axis-II diagnoses (i.e. eating disorders, bi-polar disorder,
schizophrenia and other psychotic disorders, substance-related disorders, personality
disorders, poorly controlled major depression and anxiety disorders determined by
SCID) except those allowed under Inclusions.
- Subjects currently receiving the following medications known to affect sleep(self
report):
- sedative hypnotics
- sedative antidepressants
- systemic steroids
- anticonvulsants
- histamine-1
- receptor antagonists
- narcotic analgesics
- CNS stimulants
- Body Mass Index (BMI) greater than 40.
- Pregnant, Lactating, or <6 months post-partum.
- Inability to communicate effectively with study personnel.
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
Antonella Dewell
6507368577
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.