Department of Radiation Oncology and Image-Applied Therapy, Graduate School of Medicine, Kyoto University, 54 Shogoin-Kawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan.
Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, 54 Shogoin-Kawahara-Cho, Sakyo-Ku, Kyoto, 606-8507, Japan.
Radiat Oncol. 2024 Mar 8;19(1):32. doi: 10.1186/s13014-024-02427-4.
Centrally located lung tumours present a challenge because of their tendency to exhibit symptoms such as airway obstruction, atelectasis, and bleeding. Surgical resection of these tumours often requires sacrificing the lungs, making definitive radiotherapy the preferred alternative to avoid pneumonectomy. However, the proximity of these tumours to mediastinal organs at risk increases the potential for severe adverse events. To mitigate this risk, we propose a dual-method approach: deep inspiration breath-hold (DIBH) radiotherapy combined with adaptive radiotherapy. The aim of this single-centre, single-arm phase II study is to investigate the efficacy and safety of DIBH daily online adaptive radiotherapy.
Patients diagnosed with centrally located lung tumours according to the International Association for the Study of Lung Cancer recommendations, are enrolled and subjected to DIBH daily online adaptive radiotherapy. The primary endpoint is the one-year cumulative incidence of grade 3 or more severe adverse events, as classified by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Delivering definitive radiotherapy for centrally located lung tumours presents a dilemma between ensuring optimal dose coverage for the planning target volume and the associated increased risk of adverse events. DIBH provides measurable dosimetric benefits by increasing the normal lung volume and distancing the tumour from critical mediastinal organs at risk, leading to reduced toxicity. DIBH adaptive radiotherapy has been proposed as an adjunct treatment option for abdominal and pelvic cancers. If the application of DIBH adaptive radiotherapy to centrally located lung tumours proves successful, this approach could shape future phase III trials and offer novel perspectives in lung tumour radiotherapy.
Registered at the Japan Registry of Clinical Trials (jRCT; https://jrct.niph.go.jp/ ); registration number: jRCT1052230085 ( https://jrct.niph.go.jp/en-latest-detail/jRCT1052230085 ).
中央型肺癌由于容易出现气道阻塞、肺不张和出血等症状，因此具有挑战性。这些肿瘤的手术切除往往需要牺牲肺部，因此确定性放疗是避免全肺切除的首选替代方法。然而，这些肿瘤与纵隔危险器官的接近增加了发生严重不良事件的潜在风险。为了降低这种风险，我们提出了一种双方法的方法：深吸气屏气（DIBH）放疗结合自适应放疗。这项单中心、单臂二期研究的目的是研究 DIBH 每日在线自适应放疗的疗效和安全性。
根据国际肺癌研究协会的建议，诊断为中央型肺癌的患者被纳入并接受 DIBH 每日在线自适应放疗。主要终点是根据不良事件通用术语标准（CTCAE v5.0）分类的 1 年累积 3 级或更严重不良事件的发生率。
为中央型肺癌提供确定性放疗面临着一个两难的境地，既要确保计划靶区的最佳剂量覆盖，又要考虑到不良事件风险的增加。DIBH 通过增加正常肺体积和使肿瘤远离危险的纵隔器官，从而降低毒性，为剂量学提供了可衡量的益处。DIBH 自适应放疗已被提议作为腹部和骨盆癌症的辅助治疗选择。如果 DIBH 自适应放疗在中央型肺癌中的应用取得成功，这种方法可能会影响未来的三期临床试验，并为肺癌放疗提供新的视角。
在日本临床试验注册中心（jRCT；https://jrct.niph.go.jp/）注册；注册号：jRCT1052230085（https://jrct.niph.go.jp/zh-latest-detail/jRCT1052230085）。
