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正在进行的再照射前瞻性研究:对临床试验数据库的系统评价。

Ongoing prospective studies on reirradiation: A systematic review of a clinical trials database.

作者信息

Willmann Jonas, Balermpas Panagiotis, Rimner Andreas, Appelt Ane L, Vasquez Osorio Eliana Maria, Rønde Heidi S, Day Madalyne, Embring Anna, Gabryś Dorota, Guren Marianne G, Hoskin Peter, Massaccesi Mariangela, Mayo Charles, Murray Louise, Nieder Carsten, Guckenberger Matthias, Andratschke Nicolaus

机构信息

Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.

Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.

出版信息

Radiother Oncol. 2025 Jan;202:110624. doi: 10.1016/j.radonc.2024.110624. Epub 2024 Nov 10.

DOI:10.1016/j.radonc.2024.110624
PMID:39532233
Abstract

INTRODUCTION

Reirradiation has gained increasing interest, as advances in systemic therapy increase the survival of patients with cancer, and modern radiation techniques allow more precise treatments. However, high-quality prospective evidence on the safety and efficacy of reirradiation to guide clinical practice remains scarce. This systematic review evaluates ongoing prospective studies on reirradiation to identify research gaps and priorities.

METHODS

A systematic review of ClinicalTrials.gov was conducted on July 11, 2024, using search terms related to reirradiation. Inclusion criteria were prospective studies that were "recruiting," "not yet recruiting," or "active, not recruiting." Studies with published results, retrospective, and in-silico studies were excluded. The review followed PRISMA 2020 guidelines and recommendations for systematic searches of clinical trial registries.

RESULTS

Among 1026 identified studies, 307 were screened, 99 were included. Fourty (40%) focused on central nervous system (CNS), 23 (23%) head and neck, and 17 (17%) on pelvic reirradiation. Most studies (90%) were interventional, with 32 (32%) phase II and 4 (4%) phase III trials. Sixteen trials were randomized (RCTs), including the 4 phase III trials for recurrent glioblastoma, rectal and nasopharyngeal cancer. Ten dose escalation trials focus on recurrent prostate, rectal, and non-small cell lung cancer as well as glioma. Modern high-precision radiotherapy techniques were frequently used, with 21 (21%) studies using stereotactic radiotherapy and 17 (17%) using particle therapy. Combinations with systemic therapies were investigated in 41 (41%) studies.

CONCLUSION

Ongoing studies most frequently focus on CNS, head and neck, and pelvic reirradiation. There remains a critical need for RCTs, in particular for lung, breast, and gynecological cancers. Dose escalation trials, application of precision radiation techniques and combinations with modern systemic therapy may help define the optimal multimodality treatment schedules.

摘要

引言

随着全身治疗的进展提高了癌症患者的生存率,且现代放疗技术允许更精确的治疗,再程放疗越来越受到关注。然而,关于再程放疗安全性和有效性以指导临床实践的高质量前瞻性证据仍然稀缺。本系统评价评估了正在进行的关于再程放疗的前瞻性研究,以确定研究差距和重点。

方法

2024年7月11日对ClinicalTrials.gov进行了系统评价,使用了与再程放疗相关的搜索词。纳入标准为前瞻性研究,其状态为“正在招募”“尚未招募”或“正在进行,未招募”。已发表结果的研究、回顾性研究和计算机模拟研究被排除。该评价遵循PRISMA 2020指南以及对临床试验注册库进行系统检索的建议。

结果

在1026项识别出的研究中,筛选了307项,纳入99项。40项(40%)聚焦于中枢神经系统(CNS),23项(23%)为头颈部,17项(17%)为盆腔再程放疗。大多数研究(90%)为干预性研究,其中32项(32%)为II期试验,4项(4%)为III期试验。16项试验为随机对照试验(RCT),包括4项针对复发性胶质母细胞瘤、直肠癌和鼻咽癌的III期试验。10项剂量递增试验聚焦于复发性前列腺癌、直肠癌、非小细胞肺癌以及胶质瘤。现代高精度放疗技术被频繁使用,21项(21%)研究使用立体定向放疗,17项(17%)使用粒子治疗。41项(41%)研究探讨了与全身治疗的联合应用。

结论

正在进行的研究最常聚焦于中枢神经系统、头颈部和盆腔再程放疗。仍然迫切需要进行随机对照试验,尤其是针对肺癌、乳腺癌和妇科癌症。剂量递增试验、精确放疗技术的应用以及与现代全身治疗的联合应用可能有助于确定最佳的多模式治疗方案。

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