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Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
Sponsor: University of Kansas Medical Center
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-02-25
Completion Date
2026-11
Last Updated
2023-12-07
Healthy Volunteers
No
Conditions
Interventions
Hypo-Fractionation
62.5 Gy in 25 fractions of 2.5 Gy/fraction
Standard-Fractionation
60 Gy in 30 fractions of 2 Gy/fraction
Locations (6)
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, United States
KUCC MCA- TUKHS, Saint Francis Hospital
Topeka, Kansas, United States
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, United States
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, United States
University of Kansas Cancer Center, North Kansas City Hospital
North Kansas City, Missouri, United States