Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer (PRIMER) Evaluating Safety and Treatment Break Length in Radiotherapy

What this Trial Is About

Researchers are investigating a new radiotherapy approach called primer shot fractionation for patients with stage 2 to 4 non-small-cell lung cancer (NSCLC) who are referred for palliative radiotherapy. This study aims to test the safety and feasibility of using an initial radiotherapy fraction followed by a break, allowing tumor cells to become more sensitive to treatment through reoxygenation. The trial includes a 3+3 phase with increasing treatment breaks and an expansion phase to further evaluate this method. Participants receive a total of five radiotherapy fractions of 6 Gy each, targeting the primary tumor and, if needed, lymph nodes or distant metastases. During the 3+3 phase, the break between the first and second radiation fractions is gradually increased from one to three weeks. The optimal break length determined will then be used in the expansion group. Patients are allowed to continue systemic treatments except for VEGFR inhibitors. Throughout the study, researchers monitor patients' ability to complete the full radiotherapy schedule over 5 weeks, tumor response at the end and three months after treatment, and any acute side effects. Patients also complete lung-related symptom questionnaires before treatment and during follow-up. One additional CT scan with contrast is performed at the fifth fraction to assess tumor status. The study carefully observes any risks related to longer treatment times and dropout likelihood, aiming to establish a safe and effective treatment schedule.

Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER