Randomised Phase II/III Trial of Induction Chemotherapy Followed by Continuous Hyperfractionated Accelerated Radiotherapy (CHART) Versus CHART Alone in Patients With Inoperable Non-Small Cell Lung Cancer
- Compare the overall survival of patients with stage I-III non-small cell lung cancer
treated with vinorelbine, cisplatin, and continuous hyperfractionated accelerated
radiotherapy (CHART) vs CHART alone.
- Compare the response, progression-free survival, and quality of life of patients
treated with these regimens.
- Compare the toxic effect of these regimens in these patients.
- Compare the cost effectiveness of these regimens in these patients.
- Compare the local and distant control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
- Arm I: Patients undergo continuous hyperfractionated accelerated radiotherapy (CHART) 3
times a day for 12 consecutive days.
- Arm II: Patients receive vinorelbine IV over 5-10 minutes on days 1 and 8 and cisplatin
IV over 2 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence
of disease progression or unacceptable toxicity. Beginning 4-6 weeks later, patients
undergo CHART as in arm I.
Quality of life is assessed periodically.
After completion of study treatment, patients are evaluated periodically for at least 5
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Matthew Hatton, MD
Cancer Research Centre at Weston Park Hospital
United States: Federal Government