Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2.

IF 3.4 2区 医学 Q2 ONCOLOGY BMC Cancer Pub Date : 2025-01-20 DOI:10.1186/s12885-024-13333-z
Hemant M Kocher, Peter Sasieni, Pippa Corrie, Mairéad G McNamara, Debashis Sarker, Fieke E M Froeling, Alan Christie, Roopinder Gillmore, Khurum Khan, David Propper
{"title":"Study protocol: multi-centre, randomised controlled clinical trial exploring stromal targeting in locally advanced pancreatic cancer; STARPAC2.","authors":"Hemant M Kocher, Peter Sasieni, Pippa Corrie, Mairéad G McNamara, Debashis Sarker, Fieke E M Froeling, Alan Christie, Roopinder Gillmore, Khurum Khan, David Propper","doi":"10.1186/s12885-024-13333-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Pancreatic cancer (PDAC: pancreatic ductal adenocarcinoma, the commonest form), a lethal disease, is best treated with surgical excision but is feasible in less than a fifth of patients. Around a third of patients presentlocally advanced, inoperable, non-metastatic (laPDAC), whose stadrd of care is palliative chemotherapy; a small minority are down-sized sufficiently to enable surgical excision. We propose a phase II clinical trial to test whether a combination of standard chemotherapy (gemcitabine & nab-Paclitaxel: GEM-NABP) and repurposing All Trans Retinoic Acid (ATRA) to target the stroma may extend progression-free survival and enable successful surgical resection for patients with laPDAC, since data from phase IB clinical trial demonstrate safety of GEM-NABP-ATRA combination to patients with advanced PDAC with potential therapeutic benefit.</p><p><strong>Methods: </strong>Patients with laPDAC will receive at least six cycles of GEM-NABP with 1:1 randomisation to receive this with or without ATRA to assess response, until progression or intolerance. Those with stable/responding disease may undergo surgical resection. Primary endpoint is progression free survival (PFS) defined as the time from the date of randomisation to the date of first documented tumour progression (response evaluation criteria in solid tumours [RECIST] v1.1) or death from any cause, whichever occurs first. Secondary endpoints include objective response rate (ORR), overall survival (OS), safety and tolerability, surgical resection rate, R0 surgical resection rate and patient reported outcome measures (PROMS) as measured by questionnaire EQ-5D-5L. Exploratory endpoints include a decrease or increase in CA19-9 and serum Vitamin A over time correlated with ORR, PFS, and OS.</p><p><strong>Discussion: </strong>STARPAC2 aims to assess the role of stromal targeting in laPDAC.</p><p><strong>Trial registration: </strong>EudraCT: 2019-004231-23; NCT04241276; ISRCTN11503604.</p>","PeriodicalId":9131,"journal":{"name":"BMC Cancer","volume":"25 1","pages":"106"},"PeriodicalIF":3.4000,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11748870/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12885-024-13333-z","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Pancreatic cancer (PDAC: pancreatic ductal adenocarcinoma, the commonest form), a lethal disease, is best treated with surgical excision but is feasible in less than a fifth of patients. Around a third of patients presentlocally advanced, inoperable, non-metastatic (laPDAC), whose stadrd of care is palliative chemotherapy; a small minority are down-sized sufficiently to enable surgical excision. We propose a phase II clinical trial to test whether a combination of standard chemotherapy (gemcitabine & nab-Paclitaxel: GEM-NABP) and repurposing All Trans Retinoic Acid (ATRA) to target the stroma may extend progression-free survival and enable successful surgical resection for patients with laPDAC, since data from phase IB clinical trial demonstrate safety of GEM-NABP-ATRA combination to patients with advanced PDAC with potential therapeutic benefit.

Methods: Patients with laPDAC will receive at least six cycles of GEM-NABP with 1:1 randomisation to receive this with or without ATRA to assess response, until progression or intolerance. Those with stable/responding disease may undergo surgical resection. Primary endpoint is progression free survival (PFS) defined as the time from the date of randomisation to the date of first documented tumour progression (response evaluation criteria in solid tumours [RECIST] v1.1) or death from any cause, whichever occurs first. Secondary endpoints include objective response rate (ORR), overall survival (OS), safety and tolerability, surgical resection rate, R0 surgical resection rate and patient reported outcome measures (PROMS) as measured by questionnaire EQ-5D-5L. Exploratory endpoints include a decrease or increase in CA19-9 and serum Vitamin A over time correlated with ORR, PFS, and OS.

Discussion: STARPAC2 aims to assess the role of stromal targeting in laPDAC.

Trial registration: EudraCT: 2019-004231-23; NCT04241276; ISRCTN11503604.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
研究方案:探索局部晚期胰腺癌基质靶向治疗的多中心、随机对照临床试验;STARPAC2。
背景:胰腺癌(PDAC:胰腺导管腺癌,最常见的形式)是一种致命的疾病,最好的治疗方法是手术切除,但在不到五分之一的患者中可行。大约三分之一的患者目前处于局部晚期,无法手术,非转移性(laPDAC),其标准治疗是姑息性化疗;一小部分被缩小到足以进行手术切除。我们建议进行一项II期临床试验,以测试标准化疗(吉西他滨和nap -紫杉醇:GEM-NABP)和全反式维甲酸(ATRA)联合靶向基质是否可以延长laPDAC患者的无进展生存期,并使手术切除成功,因为IB期临床试验的数据表明GEM-NABP-ATRA联合治疗晚期PDAC患者的安全性和潜在的治疗益处。方法:laPDAC患者将接受至少6个周期的GEM-NABP,以1:1随机分组,接受或不接受ATRA以评估反应,直到进展或不耐受。病情稳定或有反应者可行手术切除。主要终点是无进展生存期(PFS),定义为从随机化日期到首次记录的肿瘤进展日期(实体瘤反应评价标准[RECIST] v1.1)或任何原因死亡的时间,以先发生者为准。次要终点包括客观缓解率(ORR)、总生存期(OS)、安全性和耐受性、手术切除率、R0手术切除率和患者报告的预后指标(PROMS)(通过EQ-5D-5L问卷测量)。探索性终点包括与ORR、PFS和OS相关的CA19-9和血清维生素a随时间的减少或增加。讨论:STARPAC2旨在评估基质靶向在laPDAC中的作用。试验注册:eudraft: 2019-004231-23;NCT04241276;ISRCTN11503604。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
BMC Cancer
BMC Cancer 医学-肿瘤学
CiteScore
6.00
自引率
2.60%
发文量
1204
审稿时长
6.8 months
期刊介绍: BMC Cancer is an open access, peer-reviewed journal that considers articles on all aspects of cancer research, including the pathophysiology, prevention, diagnosis and treatment of cancers. The journal welcomes submissions concerning molecular and cellular biology, genetics, epidemiology, and clinical trials.
期刊最新文献
Integrating BRCA testing into routine prostate cancer care: a multidisciplinary approach by SIUrO and other Italian Scientific Societies. Multimodal treatments and the risk of breast cancer-related lymphedema: insights from a nationally representative cohort in South Korea. Multiple time points for detecting circulating tumor DNA to monitor the response to neoadjuvant therapy in breast cancer: a meta-analysis. Patient satisfaction with radio-frequency identification (RFID) tag localization compared with wire localization for nonpalpable breast lesions: the RFID trial. Personalized optimization of systematic prostate biopsy core number based on mpMRI radiomics features: a large-sample retrospective analysis.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1