Adaptive radiation planning to reduce side effects in lung cancer treatment
The Role of Adaptive Radiation Planning in Patients With Non-Small Cell Lung Cancer on Radiation Induced Toxicity
This study is testing if adjusting radiation treatment for lung cancer can help reduce side effects while still effectively treating the tumor in patients with stage II-IV non-small cell lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Trial ID | NCT04751747 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of adaptive radiation planning to minimize radiation-induced toxicity in patients with stage II-IV non-small cell lung cancer. Patients will undergo a series of computed tomography (CT) simulations to ensure consistent positioning during treatment, followed by standard chemoradiation therapy. The study aims to evaluate whether scheduled intervals for radiation replanning can reduce damage to healthy lung and heart tissue while maintaining effective treatment of the tumor. Participants will be monitored for side effects and overall health outcomes over a period of two years.
Who should consider this trial
Good fit: Ideal candidates include individuals with locally advanced or metastatic stage II-IV non-small cell lung cancer who are planned to receive chemoradiation and immunotherapy.
Not a fit: Patients with early-stage lung cancer or those not receiving radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the side effects of radiation therapy and improve the quality of life for lung cancer patients.
How similar studies have performed: Other studies have shown promise in adaptive radiation planning, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
New Brunswick, New Jersey and 1 other locations
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
- RWJBarnabas Health - Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Salma K Jabbour — Rutgers Cancer Institute of New Jersey
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.