Phase II Study of Carbon Ion Radiotherapy for Advanced Non-small Cell Lung Cancer in Patients Over 75 Years Old

What this Trial Is About

Researchers are evaluating the effects and safety of carbon ion radiotherapy in patients over 75 years old with locally advanced non-small cell lung cancer. This study focuses on patients who are medically inoperable or refuse surgery, aiming to observe progression-free survival, toxicity, local control, cause-specific survival, and overall survival. The study is a Phase II clinical trial targeting older adults with this condition. Participants will receive carbon ion radiotherapy with a total dose of 70 Gy divided into 20 fractions. Those with genetic mutations such as EGFR or ALK are recommended to receive targeted therapy alongside radiotherapy. For patients not suitable for targeted therapy, single regimen chemotherapy drugs like etoposide, platinum agents, vinorelbine, paclitaxel, docetaxel, pemetrexel, or gemcitabine will be given sequentially with radiotherapy. If PD-1PD-L1 immunotherapy is suitable, it may be combined or used as an alternative for those who cannot tolerate chemotherapy. During the study, participants will undergo regular follow-up visits to monitor disease progression and treatment side effects. Assessments include measuring progression-free survival from the start of radiotherapy to disease progression or death, as well as tracking treatment-related adverse events at specified intervals up to 100 months. Other outcomes such as local control rate, cause-specific survival, and overall survival are also evaluated. The study will continue monitoring participants for several years to gather comprehensive data on treatment outcomes and safety.

Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients