A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)
- Determine the local tumor control rate at 2 years after accelerated hypofractionated
3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small
cell lung cancer.
- Determine the toxicities of this regimen in these patients.
- Determine the rates of regional and distant disease recurrence in these patients.
- Determine the progression-free and overall survival of patients treated with this
- Determine the changes in pulmonary function after treatment in these patients.
- Assess the quality of life of patients after treatment.
OUTLINE: This is a multicenter, prospective study.
Patients undergo accelerated hypofractionated conformal radiotherapy 5 days a week for up to
3 weeks (15 doses) in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at week 3 of radiotherapy, at 1 month after
completion of radiotherapy, and then every 4 months for 1 year.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Local tumor control rate at 2 years
Overall tumor control rate will be assessed at 6 years
Patrick C. F. Cheung, MD, FRCPC
Edmond Odette Cancer Centre at Sunnybrook
Canada: Health Canada