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.

Efficacy and Safety of Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients (INSPiRE-ICU2)

This is a study to compare safety and efficacy of inhaled isoflurane administered via the Sedaconda ACD-S device system versus intravenous propofol for sedation of mechanically ventilated patients in the Intensive Care Unit (ICU) setting.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Isoflurane
  • drug: Propofol

Eligibility


Inclusion Criteria:

   - Adults ≥18 years of age;

   - Patients who are anticipated to require >12 hours of invasive mechanical ventilation
   and continuous sedation in the ICU; and

   - Receipt of continuous sedation due to clinical need for sedation to RASS <0.

Exclusion Criteria:

   - Need for RASS -5;

   - Sedation for invasive mechanical ventilation immediately prior to Baseline for >72
   hours;

   - Severe neurological condition before ICU admission that causes the patient to lack
   ability to participate in the study (ie, unable to be assessed for RASS and CPOT);

   - Ventilator tidal volume <200 or >1000 mL at Baseline;

   - Need for extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal
   (ECCO2R), high frequency oscillation ventilation (HFOV), or high frequency percussive
   ventilation (HFPV) at Screening;

   - Comfort care only (end of life care);

   - Contraindication to propofol or isoflurane;

   - Known or family history of MH;

   - Severe hemodynamic compromise, defined as the need for norepinephrine ≥0.3 mcg/kg/min
   (or equivalent vasopressor dose) to maintain blood pressure within acceptable range,
   assumed to be mean arterial pressure ≥65 mmHg unless prescribed clinically;

   - Allergy to isoflurane or propofol, or have propofol infusion syndrome.

   - History of ventricular tachycardia/Long QT Syndrome;

   - Requirement of IV benzodiazepine or barbiturate administration for seizures or
   dependencies, including alcohol withdrawal

   - Neuromuscular disease that impairs spontaneous ventilation (eg, C5 or higher spinal
   cord injury, amyotrophic lateral sclerosis, etc);

   - Concurrent enrollment in another study that, in the Investigator's opinion, would
   impact the patient's safety or assessments of this study;

   - Participation in other study involving investigational drug(s) or devices(s) within 30
   days prior to Randomization;

   - Anticipated requirement of treatment with continuous infusion of a neuromuscular
   blocking agent for >4 hours;

   - Female patients who are pregnant or breast-feeding;

   - Imperative need for continuous active humidification through mechanical ventilation
   circuit;

   - Attending physician's refusal to include the patient; or

   - Inability to obtain informed consent.

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
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.