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RECRUITING
NCT04992780
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

RADIATION

Hypo-Fractionation

62.5 Gy in 25 fractions of 2.5 Gy/fraction

RADIATION

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