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Radiation Therapy
Hypo-fractionated vs Standard IMRT with Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Krishna Reddy, MD, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females age ≥ 18 years
Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment for up to 7.5 years
Awards & highlights
Study Summary
This trial is testing whether a new radiation treatment plan, combined with two cancer drugs and an immunotherapy drug, can help improve cancer control in the body compared to the standard radiation treatment plan.
Who is the study for?
Adults diagnosed with Stage IIIA or IIIB non-small cell lung cancer (NSCLC) who have no brain metastases, negative PET/CT for distant metastasis, and adequate organ function. Women must not be pregnant and agree to contraception. Excluded are those with severe diseases, other treatments, infections, prior thoracic radiotherapy or certain psychiatric/social situations.Check my eligibility
What is being tested?
The trial is testing if a shorter course of high-dose radiation therapy (hypo-fractionated IMRT) combined with chemotherapy and immunotherapy improves local control of lung cancer compared to the standard longer course (standard-fractionated IMRT), followed by maintenance durvalumab.See study design
What are the potential side effects?
Possible side effects include reactions related to radiation such as skin irritation and fatigue; chemotherapy-related issues like nausea, hair loss; immunotherapy may cause immune system-related inflammation affecting various organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My lung cancer is at stage IIIA or IIIB.
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I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment for up to 7.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment for up to 7.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Locoregional control (LRC)
Secondary outcome measures
Acute toxicities
Late toxicities
Measuring the Impact of Treatment on the Quality of life (QOL)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hypo-FractionationExperimental Treatment1 Intervention
Participants will receive one fraction of radiation therapy a day for 5 days each week for 5 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin area under the curve (AUC) 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.
Group II: Standard-FractionationActive Control1 Intervention
Participants will receive one fraction of radiation therapy a day for 5 days each week for 6 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin AUC 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
462 Previous Clinical Trials
169,157 Total Patients Enrolled
Krishna Reddy, MD, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who could become pregnant must have a negative pregnancy test within one month before starting treatment.I do not have severe health issues that would affect the study.There is no evidence of cancer spread found in the PET/CT scan.My organ functions are within normal ranges according to recent tests.I've had a brain scan without signs of cancer spread, or can't have contrast for health reasons.I am not using, nor plan to use other cancer treatments while in this study.I am allergic to ingredients in the study medication.I have been diagnosed with HIV/AIDS.If I have fluid in my chest, it's been tested and is not cancerous.I am 18 years old or older.I or my legal representative can understand the study and agree to sign the consent.My lung cancer is at stage IIIA or IIIB.Your disease can be measured using a specific method called RECIST 1.1.I have an active connective tissue disorder like lupus or scleroderma.I haven't had a severe infection in the last 2 weeks.I have had radiation therapy to the chest area before.I am able to care for myself and perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Hypo-Fractionation
- Group 2: Standard-Fractionation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Hypo-Fractionation a safe treatment option for patients?
"While Phase 2 trials offer less safety data than later stage trials, our team believes that Hypo-Fractionation is safe enough to receive a 2."
Answered by AI
In how many different geographical areas is this trial taking place?
"There are six recruiting patients for this study: KUCC MCA- TUKHS, Saint Francis Hospital in Topeka, The University of Kansas Cancer Center, Lee's Summit Clinic in Lee's Summit. Other locations include The University of Kansas Cancer Center, Westwood Campus in North Kansas City and 6 other locations."
Answered by AI
Can people with the required medical history participate in this research?
"This particular trial, which was last updated on November 23rd 2021, is no longer actively recruiting patients. However, there are 1957 other trials that are still open to enrolment."
Answered by AI
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