Surgery, Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: cisplatin; gemcitabine hydrochloride; gene expression analysis; reverse transcriptase-polymerase chain reaction; immunohistochemistry staining method; adjuvant therapy; conventional surgery; radiation therapy
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) together with radiation
      therapy after surgery may kill any tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying how well surgery followed by gemcitabine, cisplatin,
      and radiation therapy works in treating patients with stage II or stage III non-small cell
      lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed single, primary bronchogenic non-small cell
             lung cancer meeting the following subtypes:

               -  Adenocarcinoma (no bronchioalveolar cell histology)

               -  Squamous cell carcinoma

               -  Large cell carcinoma

          -  Meeting the following staging criteria:

               -  Stage IIB (T2, N1, M0, or T3, N0, M0)

               -  Stage IIIA (T1-3, N2, M0 or T3, N1, M0)

               -  Stage IIIB (Any T, N3, M0 or T4, Any N, M0)

          -  No more than 1 parenchymal lesion in the same lung or in both lungs

          -  No tumor involving the superior sulcus (e.g., Pancoast tumor)

          -  Patients must undergo evaluation by the involved thoracic surgeon, medical oncologist,
             and radiation oncologist prior to registration

          -  No evidence of metastatic disease

               -  Biopsy or aspiration cytology required to confirm the benign diagnosis of CT or
                  MRI abnormalities that potentially represent metastatic disease

               -  Biopsy required if all noninvasive tests are indeterminant

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  Absolute granulocyte count ≥ 1,500/μL

          -  Platelet count ≥ 100,000/μL

          -  Bilirubin ≤ 3 times upper limit of normal (ULN)

          -  SGOT and SGPT ≤ 3 times ULN

          -  Creatinine clearance > 50 mL/min

          -  No prior malignancy except adequately treated basal cell or squamous cell skin cancer,
             carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, or
             any other cancer from which the patient has been disease-free for 5 years

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective protection

          -  No significant hearing loss or patient unwilling to accept potential for further
             hearing loss

          -  No uncontrolled medical illness by appropriate medical therapy (e.g., myocardial
             infarction within the past 3 months or liver cirrhosis)

          -  No symptomatic peripheral neuropathy affecting activities of daily living

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for lung cancer