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确定青少年和年轻成人患者在儿童肿瘤学组研究 ARST1321 的非化疗组中入组的挑战。

Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321.

机构信息

Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

Department of Pediatrics, Maine Medical Center, Portland, Maine, USA.

出版信息

J Adolesc Young Adult Oncol. 2022 Jun;11(3):328-332. doi: 10.1089/jayao.2021.0103. Epub 2021 Sep 9.

Abstract

ARST1321, a trial of patients with advanced soft tissue sarcoma, was the first National Clinical Trials Network study codeveloped by pediatric and adult consortia with two treatment cohorts. We report on the findings of a survey to identify barriers to enrolling adolescent and young adult patients (15-39 years) onto the nonchemotherapy arm. The survey response rate was 31% with a 70% completion rate. Common identified reasons for low accrual in order of decreasing frequency included insufficient funding, lack of study awareness or interest, competing trials, toxicity concerns, philosophical differences in the therapy backbone, and regulatory and infrastructure barriers. Clinical Trials.gov ID: NCT02180867.

摘要

ARST1321 是一项针对晚期软组织肉瘤患者的试验,是第一个由儿科和成人联盟共同开发的国家临床试验网络研究,该研究有两个治疗队列。我们报告了一项调查的结果,该调查旨在确定招募青少年和年轻成年患者(15-39 岁)进入非化疗组的障碍。调查的回复率为 31%,完成率为 70%。常见的低入组原因按频率降序排列,包括资金不足、缺乏研究意识或兴趣、竞争试验、毒性担忧、治疗骨干中的哲学差异以及监管和基础设施障碍。临床试验.gov 标识符:NCT02180867。

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