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

Not Recruiting

Trial ID: NCT00551369


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.

Official Title

A Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Patients With Operable Stage I/II Non-Small Cell Lung Cancer

Stanford Investigator(s)


Professor of Radiation Oncology (Radiation Therapy)



   - 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

   - 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

   - 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


   - 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


   - 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


radiation: SBRT

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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