Radiation Therapy or Observation After Chemotherapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: clinical observation; radiation therapy
Intervention description: Patients undergo observation for 6 weeks.; Patients undergo radiotherapy 5 days a week for 6 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV non-small cell lung cancer; adenosquamous 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 kill tumor cells. Sometimes, after
      chemotherapy, the tumor may not need more treatment until it progresses. In this case,
      observation may be sufficient. It is not yet known whether radiation therapy is more
      effective than observation after chemotherapy in treating non-small cell lung cancer.

      PURPOSE: This randomized phase II trial is studying how well radiation therapy works compared
      with observation after chemotherapy in treating patients with stage IV non-small cell lung
      cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

               -  Mixed histology allowed if all components are consistent with NSCLC

               -  Squamous cell histology allowed

          -  Stage IV disease

               -  Oligometastatic disease (M1 with 1-3 metastases)

                    -  Patients with M1 disease that involves intrapulmonary metastases are
                       eligible provided ≤ 40% of the total lung volume receives ≥ 20 Gy of
                       radiotherapy

          -  Previously untreated disease OR achieved stable disease or partial response within 8
             weeks after completion of 2-6 courses of standard platinum-based chemotherapy
             (administered every 3-4 weeks)

          -  Pleural effusion allowed provided it is minimal

          -  No history of or current brain metastases

               -  Patients who have had up to 3 brain metastases allowed provided they have been
                  treated with not signs of progression

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy ≥ 12 weeks

          -  Platelet count ≥ 100,00/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  WBC ≥ 2,000/mm^3

          -  Creatinine ≤ 2 times upper limit of normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Able to undergo radiotherapy, based on radiation oncology consultation

          -  Willing and able to comply with study treatment

          -  FEV_1 ≥ 1 L

          -  No requirement for daily supplemental oxygen

          -  No second primary malignancy, except for any of the following:

               -  Carcinoma in situ of the cervix

               -  Nonmelanoma skin cancer

               -  History of low-grade (Gleason score ≤ 6) localized prostate cancer, even if
                  diagnosed within the past 5 years

               -  Stage I breast cancer that was treated within the past 5 years

               -  Other malignancy that was diagnosed and definitely treated ≥ 5 years ago with no
                  subsequent evidence of recurrence

          -  No concurrent severe and/or uncontrolled medical condition, including any of the
             following:

               -  Angina pectoris

               -  Congestive heart failure within the past 3 months, unless LVEF > 40%

               -  Myocardial infarction within the past 6 months

               -  Cardiac arrhythmia

          -  No clinically significant infection

          -  No psychiatric illness or social situation that would limit compliance with study
             requirements

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior therapy for this cancer other than 2-6 courses of standard platinum-based
             chemotherapy with or without bevacizumab

          -  No prior radiotherapy to the treatment sites (e.g., primary lesion, clinically
             involved nodes, or metastatic lesions)

          -  No bevacizumab during and for 4 weeks after completion of radiotherapy

          -  No concurrent systemic chemotherapy

          -  No other maintenance systemic therapy during radiotherapy

          -  No other concurrent investigational agents for the primary neoplasm

          -  No concurrent intensity modulated radiotherapy

          -  No concurrent prophylactic nodal radiotherapy