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.

Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with chemoradiation therapy works in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, etoposide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib with chemoradiation therapy in treating patients with non-small cell lung cancer.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: cisplatin
  • drug: etoposide
  • drug: paclitaxel
  • drug: carboplatin
  • drug: crizotinib
  • radiation: Radiation Therapy
  • drug: Erlotinib

Eligibility


Inclusion Criteria:

   - Histologically or cytologically confirmed, newly diagnosed non-squamous NSCLC

   - Unresectable stage IIIA or IIIB disease; patients must be surgically staged to confirm
   N2 or N3 disease; patients may have invasive mediastinal staging by mediastinoscopy,
   mediastinotomy, endobronchial ultrasound transbronchial aspiration (EBUS-TBNA),
   endoscopic ultrasound (EUS), or video-assisted thoracoscopic surgery (VATS)

   - Patients with any tumor (T) with node (N)2 or N3 are eligible; patients with T3, N1-N3
   disease are eligible if deemed unresectable; patients with T4, any N are eligible

   - Patients must have measurable disease, i.e., lesions that can be accurately measured
   in at least 1 dimension (longest dimension in the plane of measurement is to be
   recorded) with a minimum size of 10 mm by computed tomography (CT) scan (CT scan slice
   thickness no greater than 5 mm)

   - Patients with a pleural effusion, which is a transudate, cytologically negative and
   non-bloody, are eligible if the radiation oncologist feels the tumor can be
   encompassed within a reasonable field of radiotherapy

   - If a pleural effusion can be seen on the chest CT but not on chest x-ray and is too
   small to tap, the patient will be eligible; patients who develop a new pleural
   effusion after thoracotomy or other invasive thoracic procedure will be eligible

   - The institution's pre-enrollment biomarker screening at a Clinical Laboratory
   Improvement Amendments (CLIA) certified lab documents presence of known "sensitive"
   mutations in epidermal growth factor receptor tyrosine kinase (EGFR TK) domain (exon
   19 deletion, L858) and/or EML4-anaplastic lymphoma kinase (ALK) fusion arrangement;
   either the primary tumor or the metastatic lymph node tissue may be used for testing
   of mutations

   - The institution's pre-enrollment biomarker screening at a CLIA certified lab documents
   absence of T790M mutation in the EGFR TK domain

   - Appropriate stage for protocol entry, including no distant metastases, based upon the
   following minimum diagnostic workup:

      - History/physical examination, including recording of pulse, blood pressure (BP),
      weight, and body surface area, within 45 days prior to registration

      - Whole body fludeoxyglucose-positron emission tomography (FDG-PET)/CT (orbits to
      mid-thighs) within 30 days prior to registration; PET/CT must be negative for
      distant metastasis

      - CT scan with contrast of the chest and upper abdomen to include liver and
      adrenals (unless medically contraindicated) within 30 days prior to registration

      - Magnetic resonance imaging (MRI) of the brain with contrast (or CT scan with
      contrast, if MRI medically contraindicated) within 30 days prior to registration

   - Zubrod performance status 0-1 within 14 days prior to registration

   - Absolute neutrophil count (ANC) >= 1,000 cells/mm^3

   - Platelets >= 100,000 cells/mm^3

   - Hemoglobin >= 8.0 g/dl (Note: the use of transfusion or other intervention to achieve
   hemoglobin [Hgb] >= 8.0 g/dl is acceptable)

   - Serum creatinine < 1.5 mg/dL or calculated creatinine clearance >= 50 ml/min (by
   Cockcroft-Gault formula) within 14 days prior to registration

   - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit
   of normal (ULN) within 14 days prior to registration

   - Bilirubin within normal institutional limits within 14 days prior to registration

   - Negative serum pregnancy test within 14 days prior to registration for women of
   childbearing potential

   - Patient must provide study specific informed consent prior to study entry, including
   consent for mandatory screening of tissue

Exclusion Criteria:

   - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
   for a minimum of 730 days (2 years) (for example, carcinoma in situ of the breast,
   oral cavity, or cervix are all permissible)

   - Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
   different cancer is allowable

   - Prior radiotherapy to the region of the study cancer that would result in overlap of
   radiation therapy fields

   - Atelectasis of the entire lung

   - Contralateral hilar node involvement

   - Exudative, bloody, or cytologically malignant effusions

   - Severe, active co-morbidity, defined as follows:

      - Unstable angina and/or congestive heart failure requiring hospitalization within
      the last 6 months

      - Transmural myocardial infarction within the last 6 months

      - Acute bacterial or fungal infection requiring intravenous antibiotics at the time
      of registration

      - Chronic obstructive pulmonary disease exacerbation or other respiratory illness
      requiring hospitalization or precluding study therapy at the time of
      registration; hepatic insufficiency resulting in clinical jaundice and/or
      coagulation defects

      - Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
      Control and Prevention (CDC) definition; note, however, that human
      immunodeficiency virus (HIV) testing is not required for entry into this
      protocol; protocol-specific requirements may also exclude immuno-compromised
      patients

   - Pregnancy or women of childbearing potential and men who are sexually active and not
   willing/able to use medically acceptable forms of contraception

   - Prior allergic reaction to the study drug(s) involved in this protocol

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
CCTO
650-498-7061
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.