A Multicenter, Single-Arm, Prospective Trial to Evaluate Efficacy and Safety of Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Carboplatin (DD-MVACarbo) Chemotherapy for Cisplatin-Ineligible Patients with Advanced Urothelial Cancer: Study Protocol of the CARBUNCLE Trial

Author:

Miyake Makito1ORCID,Anai Satoshi2,Iemura Yusuke3,Ichikawa Kazuki3,Miyamoto Tatsuki4,Tomioka Atsushi5,Kuwada Masaomi6,Itami Yoshitaka7,Hosokawa Yukinari7,Matsumura Yoshiaki8,Okajima Eijiro8,Torimoto Kazumasa9ORCID,Nishimura Nobutaka1,Tomizawa Mitsuru1,Shimizu Takuto1,Hori Shunta1,Morizawa Yosuke1ORCID,Gotoh Daisuke1,Nakai Yasushi1,Fujimoto Kiyohide1ORCID

Affiliation:

1. Department of Urology, Nara Medical University, Kashihara 634-8522, Nara, Japan

2. Department of Urology, Nara Prefectural Seiwa Medical Center, Ikoma 636-0802, Nara, Japan

3. Department of Urology, Yamatotakada Municipal Hospital, Yamatotakada 635-8501, Nara, Japan

4. Department of Urology, Takai Hospital, Tenri 632-0006, Nara, Japan

5. Department of Urology, Saiseikai Chuwa Hospital, Sakurai 633-0054, Nara, Japan

6. Department of Urology, Matsusaka Chuo General Hospital, Matsusaka 515-0818, Mie, Japan

7. Department of Urology, Tane General Hospital, Osaka 550-0025, Osaka, Japan

8. Department of Urology, Nara City Hospital, Nara 630-8305, Nara, Japan

9. Department of Urology, Nara Prefecture General Medical Center, Nara 630-8054, Nara, Japan

Abstract

Unresectable, metastatic, advanced urothelial carcinoma (aUC) is an aggressive disease and is treated with platinum-containing first-line chemotherapy, followed by immune checkpoint inhibitors and antibody–drug conjugates. Response to first-line chemotherapy is a vital priority in sequential treatment strategies because a better response to first-line chemotherapy is associated with a better response to subsequent therapies. Gemcitabine plus carboplatin chemotherapy is conventionally recommended for cisplatin-ineligible patients. This multicenter, single-arm prospective trial will investigate whether dose-dense methotrexate, vinblastine, doxorubicin, and carboplatin (DD-MVACarbo) chemotherapy is superior to gemcitabine plus carboplatin chemotherapy in terms of efficacy in platinum-naïve, cisplatin-ineligible patients with aUC. After screening and registration, a total of 46 patients will be treated with this novel chemotherapy regimen. The primary endpoint is the objective response rate. The secondary endpoints include disease control rate, patient-reported outcomes, and adverse events. No evidence of this novel intervention is available as of July 2024. The results are expected to change the standard of care and improve the management of patients with aUC.

Funder

Clinical Research Promotion Program grant of Nara Medical University

Publisher

MDPI AG

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3