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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
62.5 Gy in 25 fractions of 2.5 Gy/fraction
60 Gy in 30 fractions of 2 Gy/fraction
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States
RECRUITINGThe University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, United States
RECRUITINGKUCC MCA- TUKHS, Saint Francis Hospital
Topeka, Kansas, United States
NOT_YET_RECRUITINGThe University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, United States
RECRUITINGThe University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, United States
RECRUITINGUniversity of Kansas Cancer Center, North Kansas City Hospital
North Kansas City, Missouri, United States
RECRUITINGLocoregional control (LRC)
RECIST 1.1
Time frame: From enrollment for up to 7.5 years
Acute toxicities
CTCAE v. 5.0
Time frame: From enrollment for up to 7.5 years
Late toxicities
CTCAE v. 5.0
Time frame: From enrollment for up to 7.5 years
Progression free survival (PFS)
RECIST 1.1
Time frame: From enrollment for up to 7.5 years
Overall survival (OS)
Kaplan-Meier
Time frame: From enrollment for up to 7.5 years
Measuring the Impact of Treatment on the Quality of life (QOL)
EORTC Quality of Life Questionnaire (QLQ)-C30
Time frame: From enrollment for up to 7.5 years
Measuring the Impact of Treatment on the Quality of life (QOL)
QLQ-Lung Cancer (LC)29
Time frame: From enrollment for up to 7.5 years
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