A Phase III Randomized Trial Evaluating the Effect of Epoetin Alfa (Procrit) on Local Control in Patients Undergoing Concurrent Chemotherapy and Radiation Therapy for Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 1
- Locations
- 1
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified