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.
Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- radiation: radiation therapy
- drug: cyclophosphamide
- drug: cytarabine
- drug: daunorubicin hydrochloride
- drug: dexamethasone
- drug: doxorubicin hydrochloride
- drug: methotrexate
- drug: pegaspargase
- drug: prednisone
- drug: vincristine sulfate
- drug: thioguanine
- other: laboratory biomarker analysis
- other: pharmacological study
- drug: Calaspargase Pegol-mknl
- drug: Mercaptopurine
Eligibility
Inclusion Criteria:
- Patients must be eligible for and enrolled on AALL08B1 or the successor classification
study
- Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health
Organization [WHO] 2008 classification) (also termed B-precursor acute lymphoblastic
leukemia)
- White blood cell (WBC) >= 50,000/μL for patients age 1-9 OR any WBC count for patients
age 10-30 or for patients treated with prior steroids
- Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids
and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior
to registration for patient convenience; this is usually done at the time of the
diagnostic bone marrow or venous line placement to avoid a second lumbar puncture;
(Note: the CNS status must be determined based on a sample obtained prior to
administration of any systemic or intrathecal chemotherapy, except for steroid
pretreatment) systemic chemotherapy must begin within 72 hours of this intrathecal
therapy
- Patients receiving prior steroid therapy are eligible for this study; the dose and
duration of previous steroid therapy should be carefully documented
- Pregnancy tests with a negative result must be obtained in all post-menarchal females
- Lactating females must agree that they will not breastfeed a child while on this study
Exclusion Criteria:
- Patients with Down syndrome are excluded from this study
- Patients with testicular leukemia at diagnosis are excluded from this study
- Pregnant female patients are excluded from this study
Ages Eligible for Study
2 Years - 30 Years
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
Peds Hem/Onc CRAs
650-723-5535
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.