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
- 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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Arthur William Blackstock, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|