Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer
- To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated
hypofractionated radiotherapy with concurrent chemotherapy.
- To evaluate the rate of radiographic response to treatment.
- To estimate the rates of progression: local/regional/distant.
- To estimate the progression-free survival.
- To estimate the overall survival.
OUTLINE: This is a multicenter, dose-escalation study of accelerated hypofractionated
Concurrent therapy: Patients receive paclitaxel IV over 60 minutes and carboplatin IV over
30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence
of disease progression or unacceptable toxicity. Patients also undergo accelerated
hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or
intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4 to
Consolidation therapy: Beginning 4 weeks after completion of radiotherapy, patients receive
paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats
every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated RT dose fraction
James J. Urbanic, MD
Comprehensive Cancer Center of Wake Forest University
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Rebecca and John Moores UCSD Cancer Center||La Jolla, California 92093-0658|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|Mayo Clinic Hospital||Phoenix, Arizona 85054-4502|