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.
A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: recAP
- other: Placebo
Eligibility
Inclusion Criteria:
1. Signed Informed Consent Form (patient, legal representative or independent
investigator)
2. Age 18 to 85 years, inclusive
3. Is admitted to the ICU or Intermediate Care Unit
4. Has diagnosis of sepsis (< 96 hrs prior to first study drug), according to criteria
defined by the American College of Chest Physicians/Society of Critical Care Medicine:
1. Has a proven or strongly suspected bacterial infection.
2. Has at least 2 of 4 SIRS criteria 72 hrs < screening and 96 hrs < first study
drug
5. First diagnosis of AKI: AKI Stage 1 or greater, according to the AKIN criteria
(time-window adjusted):
1. Increase in serum creatinine > 26.2 µmol/L (0.30 mg/dL) in 48 hrs prior to
screening, or
2. Increase in serum creatinine to > 150% (> 1.5-fold) from reference creatinine
value in 48 hrs prior to screening
3. Urinary output < 0.5 mL/kg/h for > 6 hours following adequate fluid resuscitation
6. Continuing AKI needs to be confirmed by a confirmative fluid corrected serum
creatinine measure, or
7. When the AKI diagnosis was made according to the AKIN urine output criteria (urinary
output < 0.5 mL/kg/h for > 6 hours), the oliguria or anuria should still meet the AKIN
urine output criteria prior to randomization.
Exclusion Criteria:
1. Woman of childbearing potential with a positive pregnancy test, pregnant, or
breastfeeding.
2. Weighs more than 115 kg (253 lb).
3. Has life support limitations.
4. Is known to be human immunodeficiency virus positive.
5. Has urosepsis.
6. Is already on dialysis (RRT) or anticipated to receive RRT within 24 hours after study
drug dosing due to the underlying disease.
7. Is receiving immunosuppressant treatment or is on chronic high doses of steroids
equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant
patients. Patients with septic shock treated with hydrocortisone (e.g., 3 × 100 mg)
can be included.
8. Is expected to have rapidly fatal outcome (within 24 hours).
9. Has known, confirmed fungal sepsis.
10. Has advanced chronic liver disease, confirmed by a Child-Pugh score of 10 to 15.
11. Has acute pancreatitis with no established source of infection.
12. Has participated in another investigational study within 30 days prior to enrollment.
13. Is not expected to survive for 28 days due to medical conditions other than SA AKI,
including cancer, end-stage cardiac disease, cardiac arrest requiring cardiopulmonary
resuscitation or with pulseless electrical activity or asystole within the past 30
days, end stage lung disease, and end stage liver disease.
14. Has known prior history of Chronic Kidney Disease with a documented estimated
Glomerular Filtration Rate (eGFR) < 60 mL/min by Modification of Diet in Renal Disease
MDRD or CKD-EPI formula, known GFR < 60 mL/min, or a known history of persistent
creatinine level > 150 µmol/L (1.70 mg/dL) for reasons other than the current sepsis
condition.
15. Has diagnosis of malaria or other parasite infections.
16. Has burns on > 20% of body surface.
17. Has had AKI diagnosis according to inclusion criteria > 24 hours prior to study drug
administration.
18. Is anticipated to be treated with non-continuous RRT from Day 1 to Day 7.
19. During Day 1 to Day 7 continuous RRT is anticipated to be started or stopped not
according to per protocol criteria.
20. The AKI is most likely attributable to other causes than sepsis, such as nephrotoxic
drugs and renal perfusion-related.
21. Improvement in serum creatinine of at least 0.30 mg/dL or (26.2 µmol/L) prior to
administration of the study drug.
22. Patients who use nephrotoxic medication and who fulfill the SA-AKI inclusion criteria
at screening are not eligible if the use of this nephrotoxic medication is to continue
when alternative, medically appropriate, non-nephrotoxic medication is available.
23. Has a history of known IV drug abuse.
24. Is an employee or family member of the investigator or study site personnel.
25. Has active hematological malignancy.
Ages Eligible for Study
18 Years - 85 Years
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.