Actively Recruiting
The Role of Adaptive Radiation Planning in Patients With Non-Small Cell Lung Cancer to Reduce Radiation-Induced Toxicity
Led by Rutgers, The State University of New Jersey ยท Updated on 2026-01-30
34
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating adaptive radiation planning to see if it can reduce side effects from radiation treatment and immunotherapy in patients with stage II-IV non-small cell lung cancer. The study aims to find out if setting fixed times to redesign radiation treatment plans, regardless of tumor shrinkage, helps protect healthy lung and heart tissue and lowers cardiopulmonary toxicity. This approach could potentially establish a new standard for treating this type of lung cancer. Participants will receive computed tomography (CT) simulations with or without intravenous contrast before starting standard chemoradiation treatment lasting 40 days. Additional CT scans without contrast will be done on days 15 and 29 to adjust radiation plans. The study combines these imaging procedures with chemoradiation and immunotherapy according to usual care, focusing on adaptive planning at set intervals during treatment. During the study, patients will be monitored through imaging scans and laboratory tests, with follow-up visits at 3 to 12 weeks after treatment and every 6 months for about 2 years. Researchers will measure outcomes such as the rate of radiation-induced pneumonitis at 6 months post-treatment, changes in radiation doses to heart and lungs, toxicity levels, tumor volume reduction, and survival outcomes. Safety and side effects will be tracked throughout and after treatment.
CONDITIONS
Brief Title
Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization for health information release
- Have biopsy-proven, locally advanced stage II (inoperable), stage III, or oligometastatic stage IV non-small cell lung cancer planned for chemoradiation with concurrent or adjuvant immunotherapy
- Have an ECOG performance status of 0 or 1
- Have adequate organ and marrow function within 14 days before starting treatment
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception or abstain during the study
- Men who are sexually active with women of childbearing potential must use effective contraception with less than 1% failure rate per year
You will not qualify if you...
- Have any condition or laboratory abnormality that may interfere with participation or affect study results
- Are pregnant, breastfeeding, or planning to conceive or father children during the study
- Have active symptomatic central nervous system metastases or lack recent brain imaging to exclude them
- Received any investigational agent within 28 days before starting treatment
- Had prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to 2 cycles of consolidation therapy
- Have active second cancers
- Have psychiatric illness or social situations that limit compliance with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants undergo computed tomography (CT) simulation with or without intravenous contrast, followed by standard chemoradiation treatment. Additional CT scan simulations without contrast occur during treatment.
CT simulations on days -15 to -1, and additional CT scans on days 15 and 29; chemoradiation treatment on days 1-40
Duration - Up to 2 years
Participants are monitored after treatment completion with visits at 3 to 12 weeks, then every 6 months for about 2 years to assess long-term outcomes and toxicities.
Visits at 3 to 12 weeks post-treatment, then every 6 months for approximately 2 years
Trial Site Locations
Total: 2 locations
1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
2
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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