Last updated: December 5, 2023
Sponsor: University of Kansas Medical Center
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
Standard-Fractionation
Hypo-Fractionation
Clinical Study ID
NCT04992780
IIT-2021-LU-HypoIMRT
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Ability of participant OR Legally Authorized Representative (LAR) to understand thisstudy, and participant or LAR willingness to sign a written informed consent
- Males and females age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
- Measurable disease by RECIST 1.1
- Women of childbearing potential must have a negative serum pregnancy test within onemonth prior to initiating treatment
- Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC)
- No Positron Emission Tomography (PET)/CT evidence of metastatic disease
- An MRI of the brain with contrast excluding intracranial metastatic disease (or CTwith contrast if MRI is medically contraindicated). An MRI without contrast is onlypermitted if the subject cannot have contrast for medical reasons
- If a pleural effusion is present, it must be tapped and confirmed to be cytologicallynegative. If an effusion is deemed too small to safely tap, the subject will beeligible
- Women of child-bearing potential and men with partners of child-bearing potential mustagree to practice sexual abstinence or to use the forms of contraception listed inChild-Bearing Potential/Pregnancy section for the duration of study participation andfor 90 days following completion of therapy
- Adequate organ function per laboratory results
Exclusion
Exclusion Criteria:
- Current or anticipating use of other anti-neoplastic or investigational agents whileparticipating in this study
- Diagnosed with a psychiatric illness or is in a social situation that would limitcompliance with study requirements
- Evidence of severe or systemic disease (e.g., unstable or uncompensated respiratory,cardiac, hepatic, or renal disease) that would interfere with study protocol as judgedby the investigator
- Is pregnant or breastfeeding
- Active connective tissue disorders, such as active lupus or scleroderma
- Known Acquired Immune Deficiency (HIV (+)/AIDS)
- Has a known allergic reaction to any excipient contained in the study drugformulations
- Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungalinfection within 2 weeks prior to the first dose of study treatment
- Prior thoracic radiotherapy
Study Design
Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Standard-Fractionation
Phase: 2
Study Start date:
February 25, 2022
Estimated Completion Date:
November 30, 2026
Connect with a study center
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas 66205
United StatesActive - Recruiting
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas 66210
United StatesActive - Recruiting
KUCC MCA- TUKHS, Saint Francis Hospital
Topeka, Kansas 66606
United StatesSite Not Available
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri 64154
United StatesActive - Recruiting
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri 64064
United StatesActive - Recruiting
The University of Kansas Medical Center
North Kansas City, Missouri 64116
United StatesActive - Recruiting
University of Kansas Cancer Center, North Kansas City Hospital
North Kansas City, Missouri 64116
United StatesActive - Recruiting
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