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

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Feb 9, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to plan radiation treatment for patients with stage II-IV non-small cell lung cancer, which is a type of lung cancer that is either advanced or has spread. The goal of the study is to see if adjusting the radiation treatment plan at specific times can help reduce the side effects associated with both radiation therapy and immunotherapy, a treatment that helps the body's immune system fight cancer. As patients receive radiation, their tumors may shrink, which can cause healthy tissue to receive more radiation than intended. By changing the treatment plan at set intervals, the hope is to better protect healthy tissue and lessen side effects, even if the tumor size hasn't significantly changed.

To participate in this trial, patients should have a confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer and be planning to receive chemoradiation along with immunotherapy. Eligible participants are usually between the ages of 65 and 74, in good overall health, and able to provide informed consent. Throughout the trial, participants can expect to undergo regular assessments and adjustments to their radiation treatment plan. It's important to note that there are specific criteria for eligibility, including not having other active cancers or certain health conditions that could interfere with the study. This trial is currently recruiting participants, and if you or a loved one are interested, speaking with your healthcare provider can provide more personalized information.

Gender

ALL

Eligibility 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