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.

Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue near the tumor.

PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that can be removed by surgery.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • radiation: SBRT

Eligibility


DISEASE CHARACTERISTICS:

   - Histologically or cytologically confirmed non-small cell lung cancer, including any of
   the following primary tumor types:

      - Squamous cell carcinoma

      - Adenocarcinoma

      - Large cell carcinoma

      - Large cell neuroendocrine tumor

      - Non-small cell carcinoma not otherwise specified

   - No pure type bronchoalveolar cell carcinoma

   - Stage I or II disease based on 1 of the following combinations of primary tumor,
   regional nodes, metastasis (TNM) staging:

      - T1, N0, M0

      - T2 (≤ 5 cm), N0, M0

      - T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)

   - No T2 or T3 primary tumors > 5 cm or T3 primary tumors involving the central chest and
   structures of the mediastinum

   - No primary tumor of any T-stage within or touching the zone of the proximal bronchial
   tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree
   (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius
   bronchus, right middle lobe bronchus, lingular bronchus, or right and left lower lobe
   bronchi)

   - Patients with hilar or mediastinal lymph nodes ≤ 1 cm AND no abnormal hilar or
   mediastinal uptake on positron emission tomography (PET) scan will be considered N0

      - Patients with > 1 cm hilar or mediastinal lymph nodes on CT scan OR abnormal PET
      scan (including suspicious but nondiagnostic uptake) will still be eligible if
      directed tissue biopsies of all abnormally identified areas are negative for
      cancer

   - No direct evidence of regional or distant metastases after appropriate staging studies

   - Considered a reasonable candidate for surgical resection of the primary tumor,
   according to the following criteria:

      - Primary tumor predicted to be technically resectable with a high likelihood of
      negative surgical margins (as determined by a qualified thoracic surgeon)

      - Baseline forced expiratory volume (FEV)_1 > 35% predicted

      - Postoperative predicted FEV_1 > 30% predicted

      - Diffusion capacity > 35% predicted

      - No hypoxemia (e.g., partial pressure of arterial oxygen (PaO2) of ≤ 60 mm Hg)
      and/or hypercapnia (e.g., partial pressure of arterial carbon dioxide (PaCO2) >
      50 mm Hg) at baseline

      - No severe pulmonary hypertension

      - No severe cerebral, cardiac, or peripheral vascular disease

      - No severe chronic heart disease

   - Pleural effusion, if present, must be deemed too small to tap under CT scan guidance
   and must not be evident on chest x-ray

      - Pleural effusion that appears on chest x-ray will be allowed only after
      thoracotomy or other invasive procedure

PATIENT CHARACTERISTICS:

   - Zubrod performance status 0-1

   - Absolute neutrophil count ≥ 1,800/mm³

   - Platelet count ≥ 100,000/mm^3

   - Hemoglobin ≥ 8.0 g/dL (transfusion allowed)

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception

   - No synchronous primary or other invasive malignancy within the past 3 years other than
   nonmelanoma skin cancer or in situ cancer

   - No active systemic, pulmonary, or pericardial infection

   - No weight loss > 5% for any reason within the past 3 months

PRIOR CONCURRENT THERAPY:

   - No prior radiotherapy for lung cancer

      - Prior radiotherapy as part of treatment for head and neck cancer, breast cancer,
      or other non-lung cancer is allowed provided there will not be significant
      overlap with the stereotactic body radiotherapy fields

   - No prior chemotherapy or surgical resection for this lung cancer

   - No other concurrent local or regional antineoplastic therapy (including standard
   fractionated radiotherapy, non-approved systemic therapy, and surgery), except at
   disease progression

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
Cancer Clinical Trials Office
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.