Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Can Be Removed By Surgery
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: SBRT
Intervention description: SBRT delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; adenocarcinoma of the lung; large cell lung cancer; squamous cell lung cancer; adenosquamous cell lung cancer

Summary:

      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.
    

Eligibility criteria:

        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