Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: cisplatin; docetaxel; gemcitabine hydrochloride; pemetrexed disodium; vinorelbine tartrate; standard follow-up care
Intervention description: Given IV; Given IV; Given IV; Given IV; Given IV; Standard care
Intervention MeSH terms: Gemcitabine; Docetaxel; Pemetrexed; Vinorelbine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IA non-small cell lung cancer; stage IB non-small cell lung cancer; stage IIA non-small cell lung cancer; adenocarcinoma of the lung; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; large cell lung cancer; squamous cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel,
      gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Sometimes after
      surgery, the tumor may not need more treatment until it progresses. In this case, observation
      may be sufficient. It is not yet known whether chemotherapy is more effective than
      observation in treating patients who have undergone surgery for stage I non-small cell lung
      cancer.

      PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how
      well they work compared with observation in treating patients with early stage non-small cell
      lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed non-small cell lung cancer

               -  Any variant allowed (e.g., pure or mixed bronchioloalveolar carcinoma or
                  adenosquamous cell carcinoma)

               -  Primary tumor must be T1a, T1b, T2a, or T2b by AJCC 7.0

               -  No status

          -  Tumor measuring ≥ 2.0 cm but ≤ 7.0 cm in diameter by CT scan

               -  The mass must have a source document to verify tumor size in the greatest
                  dimension, which includes a CT scan report, a clinic note from the enrolling
                  physician, and/or a printed image with caliper measurements on the lung mass

          -  Node-negative disease

               -  Evidence of hilar or mediastinal node involvement by chest CT scan (> 1 cm
                  diameter) must be assessed with mediastinoscopy, endo-esophageal ultrasound with
                  biopsy, endo-bronchial ultrasound, bronchoscopy, or mediastinal nodal sampling
                  before or at time of thoracotomy

          -  No locally advanced or metastatic disease

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Granulocytes ≥ 1,500/μL

          -  Platelet count ≥ 100,000/μL

          -  Bilirubin ≤ 1.5 mg/dL

          -  AST < 1.5 times upper limit of normal (ULN)

          -  Serum creatinine ≤ 1.5 times ULN

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No history of prior or concurrent malignancy, except curatively treated carcinoma in
             situ of the cervix, basal cell or squamous cell carcinoma of the skin, surgically
             treated in situ carcinoma of the breast, or other cancer for which the patient has
             been disease-free for 3 years

        PRIOR CONCURRENT THERAPY:

          -  More than 3 years since prior cytotoxic or anticancer treatment

          -  No concurrent treatment with hormones or other chemotherapeutic agents, except
             steroids given for adrenal failure, hormone administered for nondisease-related
             conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an
             antiemetic

          -  No concurrent thoracic radiotherapy