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.
ARrest RESpiraTory Failure From PNEUMONIA
This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Inhaled budesonide and formoterol
- drug: Inhaled placebo
Eligibility
Inclusion Criteria:
Patients 18 years or older with
Severe pneumonia defined as:
1. Hospitalization for acute (defined as ≤ 14 days) onset of symptoms (cough, sputum
production, or dyspnea), AND 2. Radiographic evidence of pneumonia by chest radiograph or
CT scan, AND 3. One of the following:
1. Evidence of systemic inflammation (temperature < 35◦C or > 38◦C OR WBC > or < upper or
lower limits for site OR procalcitonin > 0.5 mcg/L), OR
2. Known current immunosuppression preventing inflammatory response, OR
3. High clinical suspicion of pneumonia with microbiologic confirmation of infection.
Microbiologic confirmation will include a positive nasal swab for a known respiratory
virus; a sputum culture growing a likely pathogenic organism plus moderate or greater
WBCs (not required for immunocompromised patients); or a positive blood culture with a
likely pathogenic organism - e.g., ¼ vials with S. Epidermidis would NOT qualify)
AND Hypoxemia defined as new requirement for daytime supplemental oxygen with SpO2 < 92% on
room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or non-invasive ventilation regardless of
SpO2 at enrollment. Patients admitted with pneumonia but not meeting criteria for hypoxemia
will be followed for up to 24 hours from ED admission to enrolling hospital to assess for
development of qualifying hypoxemia.
Exclusion Criteria:
- Inability to obtain consent within 24 hours of presentation to enrolling hospital (up
to 12 hours allowed at transferring ED for maximum of 36 hours from presentation)
- Intubation (or impending intubation) prior to enrollment
a. Patients receiving HFNC oxygen or NIV prior to enrollment are not excluded
- A condition requiring inhaled corticosteroids or beta-agonists (patients receiving
inhaled beta-agonists in the ED without an established indication will be eligible if
treating clinician is willing to discontinue subsequent treatments)
- Chronic systemic steroid therapy equivalent to >10 mg prednisone
- COVID-19 positive patients receiving > 6 mg dexamethasone (40 mg prednisone equivalent
dose) except for stress dose steroids for septic shock
- Non-COVID-19 pneumonia patients receiving systemic steroid > 10 mg prednisone except
for stress dose steroids for septic shock
- Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical
ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation
syndrome
- Not anticipated to survive > 48 hours or not expected to require > 48 hours of
hospitalization
- Contraindication or allergy to inhaled corticosteroids or beta-agonists
- Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular
tachycardia within last 4 hours will be potentially eligible for enrollment after the
condition has resolved
- Patients with K+ < 3.0 will be potentially eligible for enrollment after the condition
has resolved
- Patient not committed to full support other than intubation or resuscitation (i.e.,
DNR/DNI status allowed)
- Pregnancy
- Incarcerated individual
- Physician refusal of consent to protocol
- Patient/surrogate refusal of consent to protocol
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Joe Levitt, MD
650-723-6381
I'm interested
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.