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Comparing Radiation Treatments for Non-Small Cell Lung Cancer

This study is comparing two different ways to give radiation therapy (IMRT) for non-small cell lung cancer. One method, called Hypo-Fractionation, uses higher doses over fewer treatments (25 treatments of 2.5 Gy each, for a total of 62.5 Gy). The other, Standard-Fractionation, uses lower doses over more treatments (30 treatments of 2 Gy each, for a total of 60 Gy). Both groups will also receive chemotherapy (carboplatin and paclitaxel) and immunotherapy (durvalumab). The study wants to see if the Hypo-Fractionation method improves how well the cancer is controlled in the treated area. You can join if you are 18 or older, have non-small cell lung cancer, and meet other health criteria. The study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your locoregional control (how well the cancer is controlled in the treated area) will be measured for up to 7.5 years after you enroll.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04992780

Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Kansas Medical Center
~50 participants
Updated 2023-12-07 on ClinicalTrials.gov
What's tested:Hypo-FractionationStandard-Fractionation

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Locoregional control (LRC)
Measured over From enrollment for up to 7.5 years

Conditions

Non Small Cell Lung Cancer Stage

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

6 sites across 2 states
Kansas3
Missouri3

Study leadership

  • Krishna Reddy, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

Who to contact

KUCC Navigation
[email protected]
913-588-3671
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Ability of participant OR Legally Authorized Representative (LAR) to understand this study, 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 one month 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 CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons
If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible
Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 90 days following completion of therapy
Adequate organ function per laboratory results

Exclusion

Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
Diagnosed with a psychiatric illness or is in a social situation that would limit compliance 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 judged by 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 drug formulations
Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
Prior thoracic radiotherapy

What this trial measures

  • Locoregional control (LRC)From enrollment for up to 7.5 years

    RECIST 1.1