Locally Advanced Lung Non-Small Cell CarcinomaNCT04751747

Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer

A study testing Computed Tomography and Contrast Agent in people with Locally Advanced Lung Non-Small Cell Carcinoma and Metastatic Lung Non-Small Cell Carcinoma, run by Rutgers, The State University of New Jersey at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Locally Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
What is being tested?: Computed Tomography and Contrast Agent
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 2 sitesUnited States
Study dates: 11 Feb 2021to Dec 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
Histologically or cytological evidence of locally advanced, biopsy-proven, stage II (inoperable), III-or oligometastatic stage IV NSCLC planned to be treated with chemoradiation with concurrent or adjuvant immunotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and marrow laboratory values for radiation therapy deemed by appropriate the investigator obtained within 14 days prior to registration for protocol therapy
Women of childbearing potential (WOCBP) must obtain a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at day -30 to day 0
Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception during the time of the study period
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year

Who cannot join

History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the site investigator
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
Active central nervous system (CNS) metastases (if symptomatic or without prior brain imaging, subjects must undergo a head computed tomography [CT] scan or brain magnetic resonance imaging [MRI] within 28 days prior to registration for protocol therapy to exclude brain metastases)
Treatment with any investigational agent within 28 days prior to registration for protocol therapy
Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to 2 cycles of consolidation therapy
Active second cancers
History of psychiatric illness or social situations that would limit compliance with study requirements

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: The Role of Adaptive Radiation Planning in Patients With Non-Small Cell Lung Cancer on Radiation Induced Toxicity

This phase II trial studies the effect of adaptive radiation planning in reducing side effects associated with radiation treatment and immunotherapy in patients with stage II-IV non-small cell lung cancer. Prior to radiation, patients undergo simulation, where they are positioned on the treatment table in a manner that can be reproduced each time they receive treatment in order to reach the tumor exactly at the same spot each time. However, a patient's tumor may shrink as they receive radiation, exposing healthy tissue to radiation as well. Adaptive radiation planning involves re-designing a treatment plan at set intervals. The purpose of this study is to see whether establishing set time points through adaptive radiation planning, regardless of whether the doctor notices a significant decrease in tumor size, will reduce some of the side effects associated with radiation treatment and immunotherapy.

Read the detailed description

PRIMARY OBJECTIVE:

To evaluate whether implementing set intervals for radiation replanning reduces cardiopulmonary toxicity and preserves healthy lung and heart tissue, with the intention of establishing a new standard treatment modality.

OUTLINE:

Patients undergo computed tomography (CT) stimulation with or without intravenous (IV) contrast over 1.5 hours on days -15 to -1, then undergo standard of care (SOC) chemoradiation on days 1-40. Patients also undergo additional CT scan simulations without IV contrast over 20 minutes each on days 15 and 29.

After completion of study, patients are followed up at 3-12 weeks, and then every 6 months for approximately 2 years.

Conditions: Locally Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
Being tested: Computed Tomography, Contrast Agent
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo CT simulation
Contrast AgentOther
Also called Contrast, Contrast Drugs, contrast material, Contrast Medium
Given IV

Study groups in NCT04751747
Study group	Role	What they receive
Supportive care (CT simulation, contrast agent)	Experimental	Patients undergo CT stimulation with or without IV contrast over 1.5 hours on days -15 to -1, then undergo SOC chemoradiation on days 1-40. Patients also undergo additional CT scan simulations without IV contrast over 20 minutes each on days 15 and 29. Receives: Procedure: Computed Tomography; Other: Contrast Agent

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine if adaptive radiation therapy reduces radiation induced pneumonitis rates
Will be analyzed using a one-sided z-test to determine if reduction in radiation doses to organs at risk compared will result in a lower rate of pneumonitis compared to historical controls.
Measured: At 6 months post chemoradiation

Secondary outcomes (5)

Determine if adaptive radiation therapy reduces radiation doses to heart and lung
Will be compared to computed tomography simulation without adaptation of lung tumor volumes. The dosimetric parameters collected over the treatment period will be analyzed using linear mixed models with appropriate intra-correlation structures.
Measured: Baseline up to day 29 of treatment
Dosimetric changes in lung, heart, and esophageal dosimetry parameters in patients treated with adaptive radiation planning
Will be compared to computed tomography simulation without adaptation of tumor volumes. The dosimetric parameters collected over the treatment period will be analyzed using linear mixed models with appropriate intra-correlation structures.
Measured: Baseline up to day 29 of treatment
Change in toxicities, including cardiac and esophageal toxicities
Will be compared to historical controls who have not undergo adaptive re-planning at specified time points using Common Terminology Criteria for Adverse Events version 5.0.
Measured: Baseline up to 25 months after chemoradiation
Toxicity correlation to disease-free survival (DFS)/progression-free survival (PFS)/overall survival (OS)
Will determine if toxicity correlates to DFS/PFS/OS using historical controls for comparison, estimated via Kaplan-Meier product limit and compared among different toxicity levels using a log-rank test.
Measured: Up to 25 months after chemoradiation
Tumor volume reduction
Will determine if tumor volume reduction correlates to immunotherapy response.
Measured: Up to 25 months after chemoradiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 2021Dec 2027

First posted12 Feb 2021
Study start11 Feb 2021
Primary completionDec 2026 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Locally Advanced Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04751747
Sponsor's protocol ID: Pro2020002153
Other IDs: NCI-2020-08292, Pro2020002153, 032009, P30CA072720
Status last verified: Jun 2026
First submitted: 23 Dec 2020
Last updated: 11 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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