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针对中危直肠癌的器官保存的适应性放疗反应（preRADAR）：I 期剂量递增试验的方案。

Towards Response ADAptive Radiotherapy for organ preservation for intermediate-risk rectal cancer (preRADAR): protocol of a phase I dose-escalation trial.

机构信息

Department of Radiation-Oncology, University Medical Centre Utrecht, Utrecht, The Netherlands

Department of Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands.

出版信息

BMJ Open. 2023 Jun 15;13(6):e065010. doi: 10.1136/bmjopen-2022-065010.

DOI:10.1136/bmjopen-2022-065010
PMID:37321815
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10277084/
Abstract

INTRODUCTION: Organ preservation is associated with superior functional outcome and quality of life (QoL) compared with total mesorectal excision (TME) for rectal cancer. Only 10% of patients are eligible for organ preservation following short-course radiotherapy (SCRT, 25 Gy in five fractions) and a prolonged interval (4-8 weeks) to response evaluation. The organ preservation rate could potentially be increased by dose-escalated radiotherapy. Online adaptive magnetic resonance-guided radiotherapy (MRgRT) is anticipated to reduce radiation-induced toxicity and enable radiotherapy dose escalation. This trial aims to establish the maximum tolerated dose (MTD) of dose-escalated SCRT using online adaptive MRgRT. METHODS AND ANALYSIS: The preRADAR is a multicentre phase I trial with a 6+3 dose-escalation design. Patients with intermediate-risk rectal cancer (cT3c-d(MRF-)N1M0 or cT1-3(MRF-)N1M0) interested in organ preservation are eligible. Patients are treated with a radiotherapy boost of 2×5 Gy (level 0), 3×5 Gy (level 1), 4×5 Gy (level 2) or 5×5 Gy (level 3) on the gross tumour volume in the week following standard SCRT using online adaptive MRgRT. The trial starts on dose level 1. The primary endpoint is the MTD based on the incidence of dose-limiting toxicity (DLT) per dose level. DLT is a composite of maximum one in nine severe radiation-induced toxicities and maximum one in three severe postoperative complications, in patients treated with TME or local excision within 26 weeks following start of treatment. Secondary endpoints include the organ preservation rate, non-DLT, oncological outcomes, patient-reported QoL and functional outcomes up to 2 years following start of treatment. Imaging and laboratory biomarkers are explored for early response prediction. ETHICS AND DISSEMINATION: The trial protocol has been approved by the Medical Ethics Committee of the University Medical Centre Utrecht. The primary and secondary trial results will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: WHO International Clinical Trials Registry (NL8997; https://trialsearch.who.int).

摘要

简介：与全直肠系膜切除术（TME）相比，器官保存可带来更好的功能结果和生活质量（QoL）。仅 10%的患者在接受短程放疗（SCRT，25Gy 分 5 次）和延长的反应评估间隔（4-8 周）后有资格进行器官保存。通过增加放疗剂量，有可能提高器官保存率。在线自适应磁共振引导放疗（MRgRT）有望降低放疗毒性，并能使放疗剂量升级。本试验旨在使用在线自适应 MRgRT 确定剂量递增 SCRT 的最大耐受剂量（MTD）。

方法和分析：预 RADAR 是一项多中心 I 期试验，采用 6+3 剂量递增设计。有器官保存意向的中危直肠癌（cT3c-d（MRF-）N1M0 或 cT1-3（MRF-）N1M0）患者符合条件。患者在标准 SCRT 后一周内，使用在线自适应 MRgRT，对大体肿瘤体积进行 2×5Gy（0 级）、3×5Gy（1 级）、4×5Gy（2 级）或 5×5Gy（3 级）的放疗增敏。试验从剂量水平 1 开始。主要终点是基于每个剂量水平的剂量限制毒性（DLT）发生率确定的 MTD。DLT 是指接受 TME 或局部切除治疗的患者中，9 种严重放射性毒性中最多 1 种和 3 种严重术后并发症中最多 1 种的复合事件，治疗开始后 26 周内。次要终点包括器官保存率、非 DLT、肿瘤学结果、治疗开始后 2 年内患者报告的 QoL 和功能结果。还对影像学和实验室生物标志物进行了探索，以预测早期反应。

伦理和传播：试验方案已获得乌得勒支大学医学中心医学伦理委员会的批准。主要和次要试验结果将发表在国际同行评议期刊上。

试验注册号：世界卫生组织国际临床试验注册平台（NL8997；https://trialsearch.who.int）。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e400/10277084/a006d648952a/bmjopen-2022-065010f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e400/10277084/30b921f8daac/bmjopen-2022-065010f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e400/10277084/a006d648952a/bmjopen-2022-065010f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e400/10277084/30b921f8daac/bmjopen-2022-065010f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e400/10277084/a006d648952a/bmjopen-2022-065010f02.jpg

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引用本文的文献

[1]
From standardized to individualized margins for online adaptive tumor dose escalation in rectal cancer.

Radiat Oncol. 2025-8-8

[2]
Radiotherapy boost to the primary tumour in locally advanced rectal cancer: Systematic review of practices and -analysis.

Clin Transl Radiat Oncol. 2025-7-13

[3]
Dose Escalation in Neoadjuvant Chemoradiotherapy for Rectal Cancer: Short-Term Efficacy and Toxicity of VMAT-SIB vs. 3D-CRT.

Medicina (Kaunas). 2025-3-11

[4]
Repeatability of rectal cancer apparent diffusion coefficient measurements on a 1.5 T MR-linac.

Phys Imaging Radiat Oncol. 2025-1-30

[5]
Efficacy and safety of MR-guided adaptive simultaneous integrated boost radiotherapy to primary lesions and positive lymph nodes in the neoadjuvant treatment of locally advanced rectal cancer: a randomized controlled phase III trial.

Radiat Oncol. 2024-9-12

[6]
Quality of life and clinical outcomes in rectal cancer patients treated on a 1.5T MR-Linac within the MOMENTUM study.

Clin Transl Radiat Oncol. 2024-1-4

[7]
Flash Therapy for Cancer: A Potentially New Radiotherapy Methodology.

Cureus. 2023-10-12

本文引用的文献

[1]
Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy.

J Clin Oncol. 2022-8-10

[2]
Rectal Sparing Approach After Neoadjuvant Therapy in Patients with Rectal Cancer: The Preliminary Results of the ReSARCh Trial.

Ann Surg Oncol. 2022-3

[3]
ctDNA on liquid biopsy for predicting response and prognosis in locally advanced rectal cancer: A systematic review.

Eur J Surg Oncol. 2022-1

[4]
Planning target volume margin assessment for online adaptive MR-guided dose-escalation in rectal cancer on a 1.5 T MR-Linac.

Radiother Oncol. 2021-9

[5]
Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial.

Lancet Oncol. 2021-5

[6]
MR-Guided Radiotherapy for Rectal Cancer: Current Perspective on Organ Preservation.

Front Oncol. 2021-3-30

[7]
Predicting pathological response to chemoradiotherapy for rectal cancer: a systematic review.

Expert Rev Anticancer Ther. 2021-5

[8]
Radical surgery versus organ preservation via short-course radiotherapy followed by transanal endoscopic microsurgery for early-stage rectal cancer (TREC): a randomised, open-label feasibility study.

Lancet Gastroenterol Hepatol. 2021-2

[9]
Short-course radiotherapy followed by chemotherapy before total mesorectal excision (TME) versus preoperative chemoradiotherapy, TME, and optional adjuvant chemotherapy in locally advanced rectal cancer (RAPIDO): a randomised, open-label, phase 3 trial.

Lancet Oncol. 2021-1

[10]
Gut Microbiome Components Predict Response to Neoadjuvant Chemoradiotherapy in Patients with Locally Advanced Rectal Cancer: A Prospective, Longitudinal Study.

Clin Cancer Res. 2021-3-1

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