A Randomized Phase II Trial of Hypo-fractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction Versus Standard- Fractionated IMRT, Concurrent With Carboplatin/Paclitaxel and Followed by Consolidation Durvalumab, for Subjects With Stage III Non-Small Cell Lung Cancer

IF 3.9 3区医学 Q2 ONCOLOGY

Clinical lung cancer Pub Date : 2026-03-01 Epub Date: 2026-01-06 DOI:10.1016/j.cllc.2025.12.004

Krishna Reddy, Fen Wang, Ying Cao, Gregory N. Gan

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引用次数: 0

Abstract

Background

Locoregional control remains suboptimal for patients with stage III non-small cell lung cancer (NSCLC) who receive standard-of-care concurrent chemoradiation, with standard-fractionated radiation treatment (RT) delivered at 2 Gy/fraction. Hypo-fractionated RT is effectively used as a standard-of-care treatment option in several different cancers and allows escalation of the biological effective dose (BED) to the tumor, without increasing the overall treatment time. In NSCLC, hypo-fractionated RT regimens have been investigated in early phase trials and found to be feasible if performed with careful attention to the dose received by adjacent critical structures.

Methods

The study is a randomized, phase II clinical trial designed to evaluate the feasibility, toxicity and efficacy of hypo-fractionated RT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) in stage III NSCLC subjects, compared to the current standard-of care 6-week RT regimen (2 Gy/fraction), with concurrent systemic chemotherapy and consolidation immunotherapy. Our primary objective is to compare locoregional control between hypo-fractionated RT versus standard fractionated RT. Secondary objectives include comparing acute and late toxicities, progression free survival, overall survival, and quality of life.

Conclusions

This study will assess the safety and feasibility of hypo-fractionated RT at 2.5 Gy/fraction with concurrent chemotherapy and consolidation immunotherapy and is the first prospective, randomized clinical trial, to our knowledge, to compare the efficacy of hypo-fractionated RT versus standard-fractionated RT for patients with stage III non-small cell lung cancer.

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一项针对III期非小细胞肺癌患者的随机II期试验，使用2.5 Gy/次的次分级调强放疗（IMRT）与标准分级IMRT，同时使用卡铂/紫杉醇，随后使用巩固Durvalumab

背景：对于接受标准护理同步放化疗的III期非小细胞肺癌（NSCLC）患者，局部区域控制仍然不够理想，标准分次放疗（RT）以2gy /分次的速度进行。低分级放射治疗被有效地用作几种不同癌症的标准治疗选择，并允许对肿瘤的生物有效剂量（BED）增加，而不会增加总体治疗时间。在非小细胞肺癌中，低分级放疗方案已经在早期试验中进行了研究，并发现如果仔细注意相邻关键结构所接受的剂量，则该方案是可行的。该研究是一项随机的II期临床试验，旨在评估在III期NSCLC患者中，与目前的标准护理6周放疗方案（2 Gy/分次）相比，低分级放疗至62.5 Gy的25次（2.5 Gy/分次）的可行性、毒性和有效性。我们的主要目标是比较低分级放疗与标准分级放疗之间的局部区域控制。次要目标包括比较急性和晚期毒性、无进展生存期、总生存期和生活质量。本研究将评估2.5 Gy/分次低分割放疗同时化疗和巩固免疫治疗的安全性和可行性，据我们所知，这是第一个前瞻性随机临床试验，比较低分割放疗与标准分割放疗对III期非小细胞肺癌患者的疗效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical lung cancer 医学-肿瘤学

CiteScore

7.00

自引率

2.80%

发文量

159

审稿时长

24 days

期刊介绍： Clinical Lung Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of lung cancer. Clinical Lung Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of lung cancer. The main emphasis is on recent scientific developments in all areas related to lung cancer. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.