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.
Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: Native Tissue Repair for pelvic organ prolapse
- device: Elevate Apical and Posterior
Eligibility
Inclusion Criteria:
Subject is female
Subject is at least 18 years of age
Subject must have documented diagnosis of posterior or posterior and apical vaginal
prolapse with leading edge of pelvic organ prolapse at or beyond the hymen. At or beyond
the hymen is defined as POP-Q scores of Bp ≥ 0; or Bp ≥ 0 and C ≥ -1/2 TVL (for a
multi-compartment posterior prolapse that includes the apical compartment)
Subject reports a bothersome bulge they can see or feel per PFDI-20, question 3, response
of 2 or higher (i.e., responses of "somewhat", "moderately", or "quite a bit")
Subject or subject's legally authorized representative is willing to provide written
informed consent
Subject is willing and able to comply with the follow-up regimen
Exclusion Criteria:
Subject is pregnant or intends to become pregnant during the study
Subject has an active or chronic systemic infection including any gynecologic infection,
untreated urinary tract infection (UTI) or tissue necrosis
Subject has history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy
in the pelvic area
Subject has taken systemic steroids (within the last month), or immunosuppressive or
immunomodulatory treatment (within the last 3 months)
Subject has systemic connective tissue disease (e.g. scleroderma, systemic lupus
erythematosus (SLE), Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or
polymyalgia rheumatica)
Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that
involves the pelvis
Subject has uncontrolled diabetes mellitus (DM)
Subject has a known neurologic or medical condition affecting bladder function (e.g.,
multiple sclerosis, spinal cord injury or stroke with residual neurologic deficit)
Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse
(colpocleisis)
Subject is not able to conform to the modified dorsal lithotomy position
Subject is currently participating in or plans to participate in another device or drug
study during this study
Subject has a known sensitivity to polypropylene
Subject has had previous prolapse repair with mesh in the target compartment
Subject is planning to undergo a concomitant repair with use of mesh in the non-target
compartment
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
Female
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
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.