累及野放疗与选择性淋巴结区域照射在局限期（I-III 期）有淋巴结转移负荷的鼻咽癌（ISRT-NPC）或中的应用：一项多中心非劣效性随机对照 III 期临床试验研究方案。
Involved site radiation therapy in stage I-III nasopharyngeal carcinoma with limited lymph node burden (ISRT-NPC) or elective region irradiation: a study protocol for a multicenter non-inferiority randomized controlled phase III clinical trial.
机构信息
Department of Radiation Oncology, National Clinical Research Center for Cancer/Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China.
Department of Radiation Oncology, Hubei Cancer Hospital, Wuhan, 430079, Hubei Province, China.
出版信息
BMC Cancer. 2023 Aug 3;23(1):724. doi: 10.1186/s12885-023-11212-7.
BACKGROUND
Current radiotherapy guidelines and consensus statements uniformly recommend elective region irradiation (ERI) as the standard strategy for nasopharyngeal carcinoma (NPC). However, given the scarcity of skip-metastasis, the improved assessment accuracy of nodal involvement, and the striking advancements in chemotherapy for NPC, a one-fits-all delineation scheme for clinical target volumes of the nodal region (CTVn) may not be appropriate anymore, and modifications of the CTVn delineation strategy may be warranted. Involved site irradiation (ISI) covering merely the initially involved nodal site and potential extranodal extension has been confirmed to be as effective as ERI with decreased radiation-related toxicities in some malignancies, but has not yet been investigated in NPC. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of ISI with conventional ERI in NPC patients with a limited nodal burden.
METHODS
ISRT-NPC is a prospective, multicenter, open-label, noninferiority, phase III randomized controlled trial. A total of 414 patients will be randomly assigned in a 1:1 ratio to receive ISI or ERI. Randomization will be stratified by institution scale and N stage. Generally, in the ISI group, the high-risk CTV1 (dose: 60 Gy) includes a 1-cm expansion of the positive LN as well as the VIIa and the retrostyloid space above the bilateral transverse process of the atlantoaxial spine (C1), regardless of N status. The low-risk CTV2 (dose: 50 Gy) covers the cervical nodal region with a 3-cm caudal expansion below the transverse process of C1 for N0 disease and a 3-cm expansion below the positive LN for positive LNs.
DISCUSSION
The results of this trial are expected to confirm that ISI is a non-inferior strategy to ERI in stage I-III patients with low LN burden, enabling the minimization of treatment-related toxicity and improvement of long-term QoL without compromising regional control.
TRIAL REGISTRATION
ClinicalTrails.gov, NCT05145660. Registered December 6, 2021.
背景
目前的放疗指南和共识声明一致推荐选择性区域照射（ERI）作为鼻咽癌（NPC）的标准策略。然而，鉴于跳跃转移的罕见性、淋巴结受累评估准确性的提高，以及 NPC 化疗的显著进展，适用于所有临床靶区（CTVn）的统一勾画方案可能不再合适，CTVn 勾画策略的修改可能是必要的。仅覆盖最初受累淋巴结部位和潜在的结外扩展的累及部位照射（ISI）已被证实与 ERI 一样有效，且在某些恶性肿瘤中降低了放射性毒性，但尚未在 NPC 中进行研究。本研究旨在比较 ISI 与常规 ERI 在 NPC 患者中有限淋巴结负荷下的区域控制、生存结局、放射性毒性和生活质量（QoL）。
方法
ISRT-NPC 是一项前瞻性、多中心、开放性、非劣效性、III 期随机对照研究。共有 414 名患者将以 1:1 的比例随机分配接受 ISI 或 ERI。随机分组将按机构规模和 N 分期分层。一般来说，在 ISI 组中，高危 CTV1（剂量：60 Gy）包括阳性 LN 1cm 扩展以及 VIIa 和双侧寰枢椎横突后颅底空间（C1），无论 N 分期如何。低危 CTV2（剂量：50 Gy）覆盖颈部淋巴结区域，在 C1 横突下方 3cm 尾侧扩展用于 N0 疾病，在阳性 LN 下方 3cm 扩展用于阳性 LN。
讨论
该试验的结果有望证实，对于淋巴结负担低的 I-III 期患者，ISI 是 ERI 的非劣效策略，在不影响区域控制的情况下，最大限度地减少治疗相关毒性并改善长期 QoL。
试验注册
ClinicalTrials.gov，NCT05145660。于 2021 年 12 月 6 日注册。
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