A Randomized Phase III Trial of Sequential Chemotherapy Followed By Radical Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Chemotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer and Good Performance Status
- Compare the overall survival of patients with stage III non-small cell cancer treated
with chemotherapy comprising cisplatin and vinorelbine ditartrate (CV) followed by
radical radiotherapy versus concurrent CV chemoradiotherapy followed by CV
- Compare the progression-free survival of patients treated with these regimens.
- Compare the local progression-free survival (local control).
- Compare the hematological, pulmonary, esophageal, and neurological toxicities.
- Compare the response.
- Compare the quality of life.
- Compare the cost-effectiveness.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
clinically important factors. Patients are randomized to 1 of 2 treatment arms.
- Arm I (sequential treatment): Patients receive cisplatin IV over 2 hours on day 1 and
vinorelbine ditartrate IV over 5-10 minutes on days 1 and 8. Treatment repeats every 3
weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Beginning in week 15, patients undergo radiotherapy 5 days a week for 4 weeks.
- Arm II (concurrent treatment): Patients undergo radiotherapy as in arm I beginning in
week 1. Patients receive cisplatin IV over 2 hours on days 1-4 and vinorelbine
ditartrate IV over 5-10 minutes on days 1 and 8. Chemotherapy repeats every 3 weeks for
up to 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, monthly for 6 months, and then at each follow-up
After completion of study treatment, patients are followed periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 508 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment related mortality (any cause)
from randomization till death
Joe Maguire, MD
Clatterbridge Centre for Oncology
United Kingdom: Medicines and Healthcare Products Regulatory Agency