Actively Recruiting
Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
Led by University of Kansas Medical Center · Updated on 2023-12-07
50
Participants Needed
6
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability of participant or legally authorized representative to understand and sign informed consent
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status between 0 and 2
- Measurable disease by RECIST 1.1 criteria
- Negative serum pregnancy test within one month prior to treatment for women of childbearing potential
- Pathologically confirmed Stage IIIA or IIIB non-small cell lung cancer
- No PET/CT evidence of metastatic disease
- Brain MRI with contrast (or CT with contrast if MRI contraindicated) excluding intracranial metastases
- If pleural effusion present, must be tapped and cytologically negative or too small to safely tap
- Agreement to use contraception or practice abstinence during study and for 90 days after treatment
- Adequate organ function based on lab results
You will not qualify if you...
- Current or planned use of other anti-cancer investigational agents during the study
- Psychiatric illness or social situation limiting study compliance
- Severe or unstable respiratory, cardiac, liver, or kidney disease
- Pregnant or breastfeeding
- Active connective tissue diseases like lupus or scleroderma
- Known HIV infection or AIDS
- Known allergic reaction to any component of study drugs
- Active Grade 3 or higher infection within 2 weeks before treatment
- Prior thoracic radiotherapy
AI-Screening
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Trial Site Locations
Total: 6 locations
1
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States, 66205
Actively Recruiting
2
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, United States, 66210
Actively Recruiting
3
KUCC MCA- TUKHS, Saint Francis Hospital
Topeka, Kansas, United States, 66606
Not Yet Recruiting
4
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, United States, 64154
Actively Recruiting
5
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
6
University of Kansas Cancer Center, North Kansas City Hospital
North Kansas City, Missouri, United States, 64116
Actively Recruiting
Research Team
K
KUCC Navigation
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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