PET-Adjusted Intensity Modulated Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage II-IV Non-small Cell Lung Cancer
Condition: Metastatic Malignant Neoplasm in the Brain; Recurrent Non-Small Cell Lung Carcinoma; Stage IIA Non-Small Cell Lung Carcinoma; Stage IIB Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer
MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms
Intervention: Carboplatin; Computed Tomography; Intensity-Modulated Radiation Therapy; Paclitaxel; Positron Emission Tomography; Proton Beam Radiation Therapy
Intervention description: Given IV; Undergo PET-adjusted IMRT; Undergo PET-adjusted IMRT; Given IV; Undergo PET-adjusted IMRT; Undergo proton beam radiation therapy
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well intensity modulated radiation therapy adjusted by
      positron emission tomography (PET) scanning together with combination chemotherapy works in
      treating patients with stage II-IV non-small cell lung cancer (NSCLC). Radiation therapy uses
      high energy x rays to kill tumor cells. In intensity-modulated radiotherapy, multiple beam
      angles and dozens of beam segments are used to deliver highly conformal radiation therapy.
      Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to
      stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving PET-adjusted IMRT together with combination chemotherapy may kill more tumor
      cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of
             the following stages (according to the American Joint Committee on Cancer [AJCC]
             Staging Manual, 7th edition):

               -  Stage IIIA or IIIB

               -  Stage II NSCLC with medical contraindication to curative surgical resection

               -  Stage IV disease with solitary brain metastasis that has been treated radically
                  (eg: with surgical resection or stereotactic radiosurgery) and thoracic disease
                  that would be classified as stage II-III

          -  Appropriate diagnostic/staging workup, including:

               -  Complete history and physical examination

               -  Whole body PET/computed tomography (CT) scan within 42 days prior to study entry
                  demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s),
                  with a maximum standardized uptake volume (SUV) > 6 for at least one lesion; if
                  PET/CT was obtained more than 42 days prior to study entry and is not repeated,
                  CT scan of the chest within 28 days prior to study entry demonstrating stable
                  disease is required

               -  Magnetic resonance imaging (MRI) of the brain or CT scan of the head with
                  contrast within 42 days prior to study entry

               -  Biopsy confirmation of suspected metastatic disease identified by PET/CT is
                  recommended

               -  Pulmonary function tests (PFTs) within 6 weeks of study entry are highly
                  recommended but not required

          -  No prior chemotherapy or thoracic radiotherapy for lung cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count (ANC) >= 1,500 cells/ul

          -  Platelets >= 100,000 cells/ul

          -  Hemoglobin >= 9.0 g/dl (Note: the use of transfusion or other intervention to achieve
             hemoglobin [Hgb] >= 9.0 g/dl is acceptable)

          -  Total bilirubin < 3.0 times the institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x the ULN

          -  Serum creatinine =< 1.5 x ULN or calculated creatinine clearance >= 50 ml/min (by
             Cockroft-Gault formula)

          -  Women of childbearing potential must:

               -  Have a negative serum or urine pregnancy test within 72 hours prior to the start
                  of study therapy

               -  Agree to utilize an adequate method of contraception throughout treatment and for
                  at least 4 weeks after study therapy is completed

               -  Be advised of the importance of avoiding pregnancy during trial participation and
                  the potential risks of an unintentional pregnancy

          -  All patients must sign study specific informed consent prior to study entry

        Exclusion Criteria:

          -  Pleural or pericardial effusion

               -  A patient with pleural effusion may be enrolled the effusion is sampled by
                  thoracentesis and cytology is negative or the effusion is seen on axial imaging
                  but not on chest x-ray and deemed too small to tap under CT or ultrasound
                  guidance

          -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
             treatment of either a psychiatric or physical (e.g., infectious) illness

          -  Women who

               -  Are unwilling or unable to use an acceptable method to avoid pregnancy for the
                  entire study period and for at least 4 weeks after cessation of study therapy

               -  Have a positive pregnancy test at baseline

               -  Are pregnant or breastfeeding

          -  Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite
             attempts to improve glucose control by fasting duration and adjustment of medications;
             patients with diabetes will preferably be scheduled for PET/CT imaging in the morning,
             and instructions for fasting and use of medications will be provided in consultation
             with the patients' primary physicians