Surgery With or Without Internal Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: surgery; brachytherapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I non-small cell lung cancer

Summary:

      This randomized phase III trial studies surgery and internal radiation therapy to see how
      well they work compared to surgery alone in treating patients with stage I non-small cell
      lung cancer. Surgery 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.
      It is not yet known whether surgery and internal radiation therapy are more effective than
      surgery alone in treating non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PART I: PRE-OPERATIVE CRITERIA (PRE-REGISTRATION/RANDOMIZATION)

          -  Patients must have a suspicious lung nodule for clinical stage I non-small cell lung
             cancer (NSCLC)

          -  Patient must have a mass =< 3 cm maximum diameter by computed tomography (CT) size
             estimate: clinical stage Ia or selected Ib (i.e., with visceral pleural involvement)

          -  Patient must have a CT scan of the chest with upper abdomen within 60 days prior to
             date of pre-registration

          -  Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0, 1, or 2

          -  Patient must meet at least one major criteria or meet a minimum of two minor criteria
             as described below:

               -  Major criteria

                    -  Forced expiratory volume in 1 second (FEV1) =< 50% predicted

                    -  Diffusing capacity of the lungs for carbon monoxide (DLCO) =< 50% predicted

               -  Minor criteria

                    -  Age >= 75

                    -  FEV1 51-60% predicted

                    -  DLCO 51-60% predicted

                    -  Pulmonary hypertension (defined as a pulmonary artery systolic pressure
                       greater than 40 mmHg) as estimated by echocardiography or right heart
                       catheterization

                    -  Poor left ventricular function (defined as an ejection fraction of 40% or
                       less)

                    -  Resting or exercise partial pressure of oxygen (pO2) =< 55 mm Hg or
                       peripheral capillary oxygen saturation (SpO2) =< 88%

                    -  Partial pressure of carbon dioxide (pCO2) > 45 mm Hg

                    -  Modified Medical Research Council (MMRC) Dyspnea Scale >= 3

          -  Patient must not have had previous intra-thoracic radiation therapy

          -  Women of child-bearing potential must have negative serum or urine pregnancy test

          -  No prior invasive malignancy, unless disease-free for >= 5 years prior to
             pre-registration (exceptions: non-melanoma skin cancer, in-situ cancers)

          -  PART II: INTRA-OPERATIVE CRITERIA (REGISTRATION)

          -  Patient must have biopsy-proven NSCLC

          -  Patient must have all suspicious mediastinal lymph nodes (> 1 cm short-axis dimension
             on CT scan or positive on positron emission tomography [PET] scan) assessed by one of
             the following methods to confirm negative involvement with NSCLC (mediastinoscopy,
             endo-esophageal ultrasound guided needle aspiration, CT-guided, video-assisted
             thoracoscopic or open lymph node biopsy)