Chemotherapy and Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

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.
      Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients
      who are undergoing radiation therapy and chemotherapy. It is not yet known if chemotherapy
      combined with radiation therapy is more effective with or without epoetin alfa in treating
      non-small cell lung cancer.

      PURPOSE: Randomized phase III trial to determine the effectiveness of chemotherapy combined
      with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA
      or stage IIIB non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of epoetin alfa in maintaining hemoglobin levels in patients with
           stage IIIA or IIIB non-small cell lung cancer when treated with chemoradiotherapy.

        -  Compare the time to local and systemic progression in patients receiving
           chemoradiotherapy with or without epoetin alfa.

        -  Compare tumor response rate and overall survival in patients treated with these
           regimens.

        -  Compare the toxicity of these regimens in these patients.

        -  Compare quality of life in patients treated with these regimens.

        -  Compare the number of transfusions in patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      Karnofsky performance status (90-100% vs 60-80%), weight loss (no more than 5% vs 6-10%), and
      baseline hemoglobin (women 11.0-12.4 g/dL and men 11.0-13.4 g/dL vs women 12.5-15.0 g/dL and
      men 13.5-15.0 g/dL). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Beginning 7-10 days before the start of chemoradiotherapy, patients receive
           epoetin alfa subcutaneously once weekly for 8 weeks. Patients receive paclitaxel IV over
           1 hour and carboplatin IV over 30 minutes once weekly for 7 weeks. Patients undergo
           radiotherapy 5 days a week for 7 weeks for a total of 33 treatments. Treatment continues
           in the absence of disease progression or unacceptable toxicity.

        -  Arm II: Patients receive paclitaxel, carboplatin, and radiotherapy as in arm I. Quality
           of life is assessed at baseline, at completion of chemoradiotherapy, every 3 months for
           1 year, every 4 months for 1 year, and then every 6 months for 3 years.

      Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6
      months for 3 years.

      PROJECTED ACCRUAL: A total of 202-232 patients (101-116 per treatment arm) will be accrued
      for this study within 1.7-2 years.
    

Intervention name(s): epoetin alfa; carboplatin; paclitaxel; radiation therapy
Intervention type(s): Biological; Drug; Drug; Radiation
Intervention MeSH terms: Paclitaxel; Carboplatin; Epoetin Alfa
Allocation: Randomized
Primary purpose: Treatment
Keywords: squamous cell lung cancer; large cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer