Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: stereotactic body radiation therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body
      radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage
      to normal tissue.

      PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works
      in treating patients with inoperable stage I or stage II non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

               -  The following primary cancer subtypes are eligible:

                    -  Squamous cell carcinoma

                    -  Adenocarcinoma

                    -  Large cell carcinoma

                    -  Bronchoalveolar cell carcinoma

                    -  Non-small cell carcinoma not otherwise specified

          -  Stage I or II disease based on 1 of the following tumor node metastasis (TNM) stage
             criteria:

               -  T1, N0, M0

               -  T2 (≤ 5 cm), N0, M0

               -  T3 (≤ 5 cm), N0, M0 (chest wall primary tumors only)

          -  No primary tumor of any T-stage within or touching the zone of the proximal bronchial
             tree* NOTE: *Defined as a volume 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, and right and
             left lower lobe bronchi)

          -  No primary T3 tumors involving the central chest (≤ 2 cm toward carina invasion) or
             structures of the mediastinum

          -  Any hilar or mediastinal lymph nodes > 1 cm on CT scan OR demonstrating suspicious
             uptake on positron-emission tomography scan must be biopsied and confirmed negative
             for NSCLC

          -  The primary tumor must be deemed technically resectable with a reasonable possibility
             of obtaining a gross total resection with negative margins (defined as a potentially
             curative resection (PCR))

          -  Deemed medically inoperable based on pulmonary function for surgical resection of
             NSCLC secondary to an underlying physiological problem, including any of the following
             medical conditions*:

               -  Baseline forced expiratory volume (FEV)_1< 40% of predicted

               -  Postoperative predicted FEV_1 < 30% of predicted

               -  Severely reduced diffusion capacity

               -  Baseline hypoxemia and/or hypercapnia

               -  Exercise oxygen consumption < 50% of predicted

               -  Severe pulmonary hypertension

               -  Diabetes mellitus with severe end organ damage

               -  Severe cerebral, cardiac, or peripheral vascular disease

               -  Severe chronic heart disease NOTE: *Patients who refuse a PCR due to preference,
                  ideology, emotional or psychological issues, mental illness, or inability to give
                  informed consent are not eligible

          -  No evidence of regional or distant metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Cardiovascular

          -  See Disease Characteristics

          -  No active pericardial infection

        Pulmonary

          -  See Disease Characteristics

          -  No active pulmonary infection

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active systemic infection

          -  No other concurrent illness that would preclude study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No concurrent biologic therapy

          -  No concurrent vaccine therapy

        Chemotherapy

          -  No concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior lung or mediastinal radiotherapy

          -  No concurrent standard fractionated radiotherapy

          -  No concurrent intensity modulated radiotherapy

          -  No concurrent cobalt-60 or charged particle beams (including electrons, protons, or
             heavier ions)

        Surgery

          -  See Disease Characteristics

          -  No concurrent surgery

        Other

          -  No other concurrent antineoplastic therapy