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.
Descemet Endothelial Thickness Comparison Trial
The purpose of this study is to compare visual acuity outcomes of two types of endothelial keratoplasty: 1) Ultrathin Descemet's Stripping Endothelial Keratoplasty (DSAEK) or 2) Descemet's Membrane Endothelial Keratoplasty (DMEK). Half of the participants will be randomized to have DSAEK and the other half will have DMEK.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: DSAEK
- procedure: DMEK
- device: Endoserter
- drug: Prednisolone
- drug: Ofloxacin
- drug: Tropicamide
- drug: Phenylephrine
- device: Jones Tube
Eligibility
Inclusion Criteria:
- Damaged or diseased endothelium from Fuchs or Pseudophakic Bullous Keratopathy
- Good candidates for corneal transplantation for either DMEK or DSAEK
- Willingness and ability to undergo a cornea transplantation
- Willingness to participate in follow-up visits
Exclusion Criteria:
- Participants who are decisionally and/or cognitively impaired
- Participants who are not suitable for the DMEK or DSAEK surgeries
- Prior Endothelial Keratoplasty (EK) or any other ophthalmic surgery except
uncomplicated cataract surgery
- Indication for surgery that is not suitable for EK (e.g. keratoconus, stromal
dystrophies and scars)
- Presence of a condition that increases the probability for failure (e.g., heavily
vascularized cornea, uncontrolled uveitis)
- Other primary endothelial dysfunction conditions including posterior polymorphous
corneal dystrophy and congenital hereditary corneal dystrophy
- Aphakia, or anterior chamber intraocular lens (IOL) in study eye prior to or
anticipated during EK
- Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber
IOL in study at time of study EK
- Pre-operative central sub-epithelial or stromal scarring that the investigator
believes is visually significant and could impact post-operative stromal clarity
assessment
- Peripheral anterior synechiae (iris to angle) in the angle greater than a total of
three clock hours
- Hypotony (Intraocular pressure <10mmHg)
- Uncontrolled (defined as intraocular pressure >25mmHg) glaucoma Visually significant
optic nerve or macular pathology
- Visually significant optic nerve or macular pathology
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.