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NCT04751747Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 11 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
34 (estimated)
First submitted
23 Dec 2020
Start date
11 Feb 2021
Primary completion date
Dec 2026
Lead sponsor
Rutgers, The State University of New Jersey
Diseases
Lung cancer
NCT number
NCT04751747

What you commit to

  • Study type: Interventional
  • Planned participants: 34
  • From 11 Feb 2021 to the primary completion date, Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Active second cancers
  • History of psychiatric illness or social situations that would limit compliance with study requirements

Lab values

  • 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

Other

  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
RWJBarnabas Health - Robert Wood Johnson University Hospital
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.