A Randomized Phase II Trial of Hypo-fractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction Versus (VS) Standard-Fractionated IMRT, Concurrent With Carboplatin/Paclitaxel and Followed by Consolidation Durvalumab, for Subjects With Stage 2A/B Non-Small Cell Lung Cancer
Summary
The hypothesis for this study is that hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with concurrent carboplatin and paclitaxel, followed by maintenance durvalumab will improve locoregional control at 18 months by 10% compared to standard-fractionated chemo-IMRT/durvalumab. A modest improvement in locoregional control (LRC) was selected as a target which could merit further study of this hypofractionated IMRT regimen in a Phase III trial
Arms & interventions
- RadiationHypo-Fractionation
62.5 Gy in 25 fractions of 2.5 Gy/fraction
- RadiationStandard-Fractionation
60 Gy in 30 fractions of 2 Gy/fraction
Outcome measures
Primary
Locoregional control (LRC)
RECIST 1.1
Time frame: From enrollment for up to 7.5 years
Secondary
Acute toxicities
Time frame: From enrollment for up to 7.5 years
Late toxicities
Time frame: From enrollment for up to 7.5 years
Progression free survival (PFS)
Time frame: From enrollment for up to 7.5 years
Overall survival (OS)
Time frame: From enrollment for up to 7.5 years
Measuring the Impact of Treatment on the Quality of life (QOL)
Time frame: From enrollment for up to 7.5 years
Measuring the Impact of Treatment on the Quality of life (QOL)
Time frame: From enrollment for up to 7.5 years
Eligibility criteria
Study locations (6)
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, 66210
KUCC MCA- TUKHS, Saint Francis Hospital
Topeka, Kansas, 66606
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, 64154
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, 64064
University of Kansas Cancer Center, North Kansas City Hospital
North Kansas City, Missouri, 64116