Abhishek A Solanki, Kevin Zheng, Alicia N Skipworth, Lisa M Robin, Ryan F Leparski, Elizabeth Henry, Matthew Rettig, Joseph K Salama, Timothy Ritter, Jeffrey Jones, Marcus Quek, Michael Chang, Alec M Block, James S Welsh, Aryavarta Kumar, Hann-Hsiang Chao, Albert C Chen, Ronald Shapiro, Rhonda L Bitting, Robert Kwon, William Stross, Lindsay Puckett, Yu-Ning Wong, Nicholas G Nickols, Kimberly Carlson
{"title":"在美国退伍军人事务医疗保健系统中发展肿瘤临床试验网络的挑战与机遇:退伍军人事务部 STARPORT 经验。","authors":"Abhishek A Solanki, Kevin Zheng, Alicia N Skipworth, Lisa M Robin, Ryan F Leparski, Elizabeth Henry, Matthew Rettig, Joseph K Salama, Timothy Ritter, Jeffrey Jones, Marcus Quek, Michael Chang, Alec M Block, James S Welsh, Aryavarta Kumar, Hann-Hsiang Chao, Albert C Chen, Ronald Shapiro, Rhonda L Bitting, Robert Kwon, William Stross, Lindsay Puckett, Yu-Ning Wong, Nicholas G Nickols, Kimberly Carlson","doi":"10.3390/curroncol31080358","DOIUrl":null,"url":null,"abstract":"<p><p>The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)-the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study. In this manuscript, we describe several challenges we encountered in study development/conduct and our strategies to address them, with the goal of helping investigators establish robust study networks to conduct clinical trials. In the study start-up, we encountered challenges in timely site activation, and leveraged project management to maximize efficiency. Additionally, there were several changes in the clinical paradigms in imaging and treatment that led to protocol amendments to ensure maximum equipoise, recruitment, and impact of the study. Specifically, we amended the trial to add de novo OMPC patients (from initially only recurrent OMPC) and expanded the study to allow up to 10 metastases (from initially five). Finally, in order to maintain local study team engagement, we developed initiatives to maximize collaboration and add value to the overall clinical program through study participation.</p>","PeriodicalId":11012,"journal":{"name":"Current oncology","volume":null,"pages":null},"PeriodicalIF":2.8000,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11353739/pdf/","citationCount":"0","resultStr":"{\"title\":\"Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience.\",\"authors\":\"Abhishek A Solanki, Kevin Zheng, Alicia N Skipworth, Lisa M Robin, Ryan F Leparski, Elizabeth Henry, Matthew Rettig, Joseph K Salama, Timothy Ritter, Jeffrey Jones, Marcus Quek, Michael Chang, Alec M Block, James S Welsh, Aryavarta Kumar, Hann-Hsiang Chao, Albert C Chen, Ronald Shapiro, Rhonda L Bitting, Robert Kwon, William Stross, Lindsay Puckett, Yu-Ning Wong, Nicholas G Nickols, Kimberly Carlson\",\"doi\":\"10.3390/curroncol31080358\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). 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Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience.
The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)-the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study. In this manuscript, we describe several challenges we encountered in study development/conduct and our strategies to address them, with the goal of helping investigators establish robust study networks to conduct clinical trials. In the study start-up, we encountered challenges in timely site activation, and leveraged project management to maximize efficiency. Additionally, there were several changes in the clinical paradigms in imaging and treatment that led to protocol amendments to ensure maximum equipoise, recruitment, and impact of the study. Specifically, we amended the trial to add de novo OMPC patients (from initially only recurrent OMPC) and expanded the study to allow up to 10 metastases (from initially five). Finally, in order to maintain local study team engagement, we developed initiatives to maximize collaboration and add value to the overall clinical program through study participation.
期刊介绍:
Current Oncology is a peer-reviewed, Canadian-based and internationally respected journal. Current Oncology represents a multidisciplinary medium encompassing health care workers in the field of cancer therapy in Canada to report upon and to review progress in the management of this disease.
We encourage submissions from all fields of cancer medicine, including radiation oncology, surgical oncology, medical oncology, pediatric oncology, pathology, and cancer rehabilitation and survivorship. Articles published in the journal typically contain information that is relevant directly to clinical oncology practice, and have clear potential for application to the current or future practice of cancer medicine.