Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: therapeutic conventional surgery; iodine I 125; stereotactic body radiation therapy
Intervention description: Undergo surgery; Undergo seed implant radiotherapy; Undergo radiotherapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IA non-small cell lung cancer; stage IB non-small cell lung cancer

Summary:

      RATIONALE: Surgery with or without internal radiation therapy may be an effective treatment
      for non-small cell lung cancer. Internal radiation uses radioactive material placed directly
      into or near a tumor to kill tumor cells. Stereotactic body radiation therapy may be able to
      send x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known
      whether stereotactic body radiation therapy is more effective than surgery with or without
      internal radiation therapy in treating non-small cell lung cancer.

      PURPOSE: This randomized phase III trial is studying how well surgery with or without
      internal radiation therapy works compared with stereotactic body radiation therapy in
      treating patients with high-risk stage IA or stage IB non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Lung nodule suspicious for non-small cell lung cancer (NSCLC)

               -  Biopsy confirmation is strongly recommended but not required; if biopsy is
                  attempted and non-diagnostic, if the patient refuses biopsy, or if the risk of
                  biopsy is considered too high, patients may be enrolled if the mass is suspicious
                  for NSCLC based on two or more of the following criteria:

                    -  Positive smoking history

                    -  Absence of benign calcifications within suspicious nodule

                    -  Activity on PET greater than normal tissue

                    -  Evidence of growth compared to previous imaging

                    -  Presence of spiculation

          -  Tumor ≤ 4 cm maximum diameter, clinical stage IA or selected IB (i.e., with visceral
             pleural involvement) by PET/CT scan of the chest and upper abdomen performed within 60
             days prior to registration

          -  All clinically suspicious mediastinal N1, N2, or N3 lymph nodes (> 1 cm short-axis
             dimension on CT scan and/or positive on PET scan) confirmed negative for involvement
             with NSCLC by one of the following methods: mediastinoscopy, anterior mediastinotomy,
             endoscopic and/or endobronchial ultrasonography (EUS/EBUS)-guided needle aspiration,
             CT-guided, or video-assisted thoracoscopic or open lymph node biopsy

          -  Tumor verified by a thoracic surgeon to be in a location that will permit sublobar
             resection

          -  Tumor located peripherally within the lung, defined as not touching any surface within
             2 cm of the proximal bronchial tree in all directions

               -  Patients with non-peripheral (central) tumors are NOT eligible

          -  No evidence of distant metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status (PS) 0, 1, or 2

          -  Patient at high-risk for surgery by meeting a minimum of one major criteria or two
             minor criteria as described below:

               -  Major criteria

                    -  FEV1 ≤ 50% predicted

                    -  DLCO ≤ 50% predicted

               -  Minor criteria

                    -  Age ≥ 75 years

                    -  FEV1 51-60% predicted

                    -  DLCO 51-60% predicted

                    -  Pulmonary hypertension (defined as a pulmonary artery systolic pressure
                       greater than 40 mm Hg) as estimated by echocardiography or right heart
                       catheterization

                    -  Poor left ventricular function (defined as an ejection fraction of 40% or
                       less)

                    -  Resting or exercise arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88%

                    -  pCO2 > 45 mm Hg

                    -  Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3

          -  Not pregnant or nursing

          -  Negative urine or serum pregnancy test

          -  Fertile patients must use effective contraception

          -  No prior invasive malignancy, unless disease-free for ≥ 3 years prior to registration
             (except non-melanoma skin cancer, in-situ cancers).

        PRIOR CONCURRENT THERAPY:

          -  No prior intra-thoracic radiotherapy

               -  Prior radiotherapy as part of treatment for head and neck, breast, or other
                  non-thoracic cancer is permitted

          -  Prior chemotherapy or surgical resection for the lung cancer being treated on this
             protocol is NOT permitted