Proton therapy’s direct and precise application of radiation for mid-stage lung cancer is being investigated in an ongoing phase III trial.1
The proton therapy is being assessed against standard radiation, according to the researchers at the University of Cincinnati, one of the trial sites.
The patient pool includes an estimated 330 participants diagnosed with stage II-IIIB non-small cell lung cancer (NSCLC) that cannot be removed by surgery.2
Patients will be randomized to undergo either proton or standard radiation treatments, and monitored for 2 years on the basis of cancer control, adverse events (AEs), and quality-of-life outcomes, said Emily Daugherty, MD, assistant professor of radiation oncology at the University of Cincinnati and a UC Health radiation oncologist.
“Radiation may negatively impact the normal function of the lungs and the esophagus,” said Daugherty, who serves as the principal investigator of the study in Cincinnati. “We want to see if a more targeted approach could eliminate some of these residual problems.”
The control photon group will undergo the therapy 5 days each week for a total of 35 fractions and receive either paclitaxel plus carboplatin, both intravenously, weekly, or etoposide intravenously on days 1 to 5 and 29 to 33 of each cycle, and cisplatin intravenously on days 1, 8, 29, and 36 of each cycle.
The proton therapy group will undergo the therapy 5 days a week for a total of 35 fractions, and receive either paclitaxel and carboplatin, etoposide and cisplatin, or pemetrexed and carboplatin. Patients in both arms who receive paclitaxel and carboplatin will receive 2 courses of consolidation therapy.
The primary objective is to look at overall survival as compared between the two arms of the trial, as well as the cardiac toxicity and reduction of lymphocytes between the 2 groups.
Secondary objectives include progression-free survival at the 2-year mark, safety, quality of life, and also cost-effectiveness between the 2 options.
The estimated primary completion is estimated for December 2020.
Proton therapy is also being investigated at the University of Cincinnati in esophageal, liver, and breast cancers.
1. University of Cincinnati. UC study examines new treatment for cancer. Available from: https://www.uc.edu/news/articles/2019/10/n20869147.html. Accessed: November 7, 2019.
2. Radiation Therapy Oncology Group. Comparing Photo Therapy to Proton Therapy to Treat Patients with Lung Cancer. Available at https://clinicaltrials.gov/ct2/show/NCT01993810. NLM identifier: NCT01993810. Accessed November 6, 2019.