Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Cisplatin; Etoposide; Radiation therapy
Intervention description: 60 mg/m2 given intravenously. During RT, give on day 1 and day 22. After completion of RT, on days 43 and 64.; 120 mg/m2 given intravenously. During RT, give on days 1-3, then days 22-24. After completion of RT, on days 43-45 and days 64-66.; Large field 28.8 Gy: 1.8 Gy per fraction, 5 days per week for 16 fractions. On days 23-26, BID: use anteroposterior and posteroanterior (AP/PA) fields in a.m. at 1.8 Gy per fraction; boost with 2nd treatment in p.m. at 1.8 Gy per fraction. Then off-cord boost, 1.8 Gy, BID, x last 5 days for a total dose of 61.2 Gy in 5 wks.
Intervention MeSH terms: Etoposide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: limited stage small cell lung cancer

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together
      with radiation therapy works in treating patients with limited-stage small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed small cell carcinoma of the lung by fine
             needle aspiration biopsy or two positive sputa

          -  Must have limited disease

               -  Stage I, II, IIIA, or IIIB

                    -  Confined to 1 hemithorax, but excluding the following:

                         -  T4 tumor based on malignant pleural effusion

                         -  N3 disease based on contralateral hilar or contralateral
                            supraclavicular involvement

          -  No pericardial or pleural effusions on chest x-ray (regardless of cytology)

          -  Measurable or evaluable disease

          -  Tumor must be able to be encompassed by limited radiotherapy fields without
             significantly compromising pulmonary function

          -  No prior complete tumor resection

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 100

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute granulocyte count at least 1,500/mm^3

          -  Platelet count at least 150,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.5 mg/dL

        Renal

          -  Creatinine no greater than 1.5 mg/dL

        Cardiovascular

          -  No myocardial infarction within the past 6 months

          -  No symptomatic heart disease

        Pulmonary

          -  No chronic obstructive pulmonary disease with Forced Expiratory Volume (FEV)-1 no
             greater than 0.8 liter

          -  No uncontrolled bronchospasm in the unaffected lung

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Available for follow-up

          -  No other malignancy within the past 2 years except curatively treated basal cell or
             squamous cell skin cancer or non-invasive in situ malignancies

          -  No other concurrent serious medical illness

          -  No uncontrolled psychiatric illness

          -  No chronic alcohol or drug abuse

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiotherapy to the chest or other area containing a large amount of bone
             marrow (e.g., more than 75% of pelvic bone)

        Surgery

          -  See Disease Characteristics