Radiotherapy(R) Integration(I) Strategy for Small(S)-Cell Lung Cancer in Extensive(E) Stage (RISE) with up to 10 metastases- a study protocol of a randomized phase II trial

作者：Łukasz Kuncman, Jacek Fijuth, Damian Tworek, Ewa Sierko, Paweł Cisek, Michał Masłowski, Maja Lisik-Habib, Magdalena Orzechowska, K. Galwas-Kliber, Adam Antczak, Izabela Chmielewska, Barbara Ziółkowska, Marta Kurczewska-Michalak, Wojciech Kuźnicki, Nina Jędrzejczak, Kinga Ranoszek, Mateusz Bilski · 发表于：BMC Cancer · 年份：2025 · DOI：10.1186/s12885-025-13552-y · 被引用次数：14 · 研究领域：Lung Cancer Research Studies、Lung Cancer Diagnosis and Treatment、Radiopharmaceutical Chemistry and Applications

BACKGROUND: The current standard of care (SoC) for patients with extensive-disease small-cell lung cancer (ED-SCLC) is chemo-immunotherapy. The efficacy of radiotherapy (RT) for chest consolidation has been established for patients with ED-SCLC who have responded to chemotherapy. There is a lack of data on incorporating RT as chest consolidation and metastasis-directed therapy for ED-SCLC. The RISE (Radiotherapy for Extensive-Stage Small-Cell Lung Cancer) study aims to evaluate the effectiveness of different RT strategies for residual lesions for patients with ED-SCLC who receive chemo-immunotherapy. METHODS: A total of 165 patients with ED-SCLC will be recruited, with 55 patients assigned to each of the three study arms. Patients with stabilization or partial regression, according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, during chemo-immunotherapy will be included. • Arm I will serve as the control group, comprising patients who continue SoC of programmed death-ligand 1 (PD-L1)/programmed death-1 (PD-1) immunotherapy (durvalumab or atezolizumab) following platinum-based chemo-immunotherapy. • Arm II will receive the SoC with consolidative RT to the chest area and potentially, according to palliative indications to metastatic lesions, delivered in 30 Gy in 3-Gy fractions. • Arm III will receive SoC with RT of 45 Gy in 3-Gy fractions to the chest area and stereotactic body radiotherapy (SBRT) with 24 Gy in 8-Gy fractions to the metastatic lesio...