Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stag… (NCT04751747) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer
United States34 participantsStarted 2021-02-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 expec…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically trying to reduce radiation-induced pneumonitis — how does that risk compare to what I'd face with standard radiation planning for my stage of non-small cell lung cancer?
2Since this trial is listed as 'active, not recruiting,' does that mean enrollment is closed, and if so, are there similar adaptive radiation planning approaches or other trials still open that I might be eligible for?
3Adaptive radiation planning involves adjusting the treatment as it goes — what does that mean practically for me in terms of extra scans, appointments, or time commitment compared to a conventional radiation course?
4This trial covers a wide range of stages from Stage II all the way through Stage IV — given my specific stage and whether my tumor is resectable or not, would adaptive radiation therapy even be the recommended approach for my situation?
5Since this study doesn't list a traditional Phase I, II, or III classification, what does that tell us about how much is already known about the safety and effectiveness of this approach, and how should that factor into my decision-making?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine if adaptive radiation therapy reduces radiation induced pneumonitis rates
Timeframe: At 6 months post chemoradiation
Trial details
NCT IDNCT04751747
SponsorRutgers, The State University of New Jersey