Phase III Randomized Study of Paclitaxel and Carboplatin or Cisplatin Followed by Radiotherapy With or Without Concurrent Paclitaxel in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
- Compare the overall survival rate of patients with unresectable stage III non-small
cell lung cancer treated with paclitaxel and carboplatin or cisplatin followed by
radiotherapy with or without concurrent paclitaxel.
- Compare the 1-year survival rate and mean survival time in patients treated with these
- Compare the objective response rate and local control in patients treated with these
- Compare the tolerability of these regimens in these patients.
- Compare the safety profile and toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes
or cisplatin IV on day 1. Treatment repeats every 21 days for 2 courses. Patients then
proceed to randomized treatment.
- Arm I: Patients receive paclitaxel IV over 1 hour on day 1 and radiotherapy on days 1-5
of each week for 6 weeks.
- Arm II: Patients receive radiotherapy 5 days a week for 7 weeks. Patients are followed
every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Overall survival rate
Paolo Bruzzi, MD, MPH, PhD
National Institute for Cancer Research, Italy
United States: Federal Government