Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated
hypofractionated radiotherapy with concurrent chemotherapy.
Secondary
- 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
radiotherapy.
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
5.5 weeks.
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated RT dose fraction
No
James J. Urbanic, MD
Principal Investigator
Comprehensive Cancer Center of Wake Forest University
Unspecified
CDR0000719011
NCT01486602
March 2012
Name | Location |
---|---|
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 |