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.

Reevaluation Of Systemic Early Neuromuscular Blockade

This study evaluates whether giving a neuromuscular blocker (skeletal muscle relaxant) to a patient with acute respiratory distress syndrome will improve survival. Half of the patients will receive a neuromuscular blocker for two days and in the other half the use of neuromuscular blockers will be discouraged.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Cisatracurium Besylate

Eligibility


Inclusion Criteria

   1. Age > 18 years

   2. Presence of all of the following conditions for < 48 hours:

   i. PaO2/FiO2 < 150 with PEEP >/= 8 cm H2O OR, if ABG not available, SaO2/FiO2 ratio
   that is equivalent to a PaO2/FiO2 < 150 with PEEP >/= 8 cm H2O , and a confirmatory
   SaO2/FiO2 ratio that is again equivalent 1-6 hours later

ii. Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules.

iii. Respiratory failure not fully explained by cardiac failure or fluid overload; need
objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk
factor present.

Patients must be enrolled within 48 hours of meeting inclusion criteria.

Exclusion Criteria:

   1. Lack of informed consent

   2. Continuous neuromuscular blockade at enrollment

   3. Known pregnancy

   4. Currently receiving ECMO therapy

   5. Chronic respiratory failure defined as PaCO2 > 60 mm Hg in the outpatient setting

   6. Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for
   CPAP/BIPAP used solely for sleep-disordered breathing

   7. Actual body weight exceeding 1 kg per centimeter of height

   8. Severe chronic liver disease defined as a Child-Pugh score of 12-15 (Appendix A2)

   9. Bone marrow transplantation within the last 1 year

10. Expected duration of mechanical ventilation of < 48 hours

11. Decision to withhold life-sustaining treatment; except in those patients committed to
   full support except cardiopulmonary resuscitation if an actual cardiac arrest occurs

12. Moribund patient not expected to survive 24 hours; if CPR provided, assess for
   moribund status greater than 6 from CPR conclusion

13. Diffuse alveolar hemorrhage from vasculitis

14. Burns > 70% total body surface

15. Unwillingness to utilize the ARDS Network 6 ml/kg IBW ventilation protocol

16. Previous hypersensitivity or anaphylactic reaction to cisatracurium

17. Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair
   spontaneous ventilation (Appendix A2)

18. Neurologic conditions undergoing treatment for intracranial hypertension

19. Enrollment in an interventional ARDS trial with direct impact on neuromuscular
   blockade and PEEP

20. >120 hours of mechanical ventilation

21. P/F < 200 mmHg at the time of randomization (if available)

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
SPECTRUM
6507236576
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.

Stanford APBI Trial