Hypo-Fractionation
Radiation62.5 Gy in 25 fractions of 2.5 Gy/fraction
NCT Number: NCT04992780
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
The University of Kansas Cancer Center, Westwood Campus, Kansas City, Kansas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
62.5 Gy in 25 fractions of 2.5 Gy/fraction
60 Gy in 30 fractions of 2 Gy/fraction
Time frame: From enrollment for up to 7.5 years
RECIST 1.1
Time frame: From enrollment for up to 7.5 years
CTCAE v. 5.0
Time frame: From enrollment for up to 7.5 years
CTCAE v. 5.0
Time frame: From enrollment for up to 7.5 years
RECIST 1.1
Time frame: From enrollment for up to 7.5 years
Kaplan-Meier
Time frame: From enrollment for up to 7.5 years
EORTC Quality of Life Questionnaire (QLQ)-C30
Time frame: From enrollment for up to 7.5 years
QLQ-Lung Cancer (LC)29
Contact information is provided by the study sponsor or research team.
University of Kansas Medical Center
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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