射频消融与化疗联合化疗对比单纯化疗治疗局部晚期胰腺癌（PELICAN）：一项随机对照试验的研究方案
Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial.
作者信息
Walma M S, Rombouts S J, Brada L J H, Borel Rinkes I H, Bosscha K, Bruijnen R C, Busch O R, Creemers G J, Daams F, van Dam R M, van Delden O M, Festen S, Ghorbani P, de Groot D J, de Groot J W B, Haj Mohammad N, van Hillegersberg R, de Hingh I H, D'Hondt M, Kerver E D, van Leeuwen M S, Liem M S, van Lienden K P, Los M, de Meijer V E, Meijerink M R, Mekenkamp L J, Nio C Y, Oulad Abdennabi I, Pando E, Patijn G A, Polée M B, Pruijt J F, Roeyen G, Ropela J A, Stommel M W J, de Vos-Geelen J, de Vries J J, van der Waal E M, Wessels F J, Wilmink J W, van Santvoort H C, Besselink M G, Molenaar I Q
机构信息
Departments of Surgery, Radiology and Medical Oncology, UMC Utrecht Cancer Center and St Antonius Hospital Nieuwegein: Regional Academic Cancer Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.
Departments of Surgery, Radiology and Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
出版信息
Trials. 2021 Apr 29;22(1):313. doi: 10.1186/s13063-021-05248-y.
BACKGROUND
Approximately 80% of patients with locally advanced pancreatic cancer (LAPC) are treated with chemotherapy, of whom approximately 10% undergo a resection. Cohort studies investigating local tumor ablation with radiofrequency ablation (RFA) have reported a promising overall survival of 26-34 months when given in a multimodal setting. However, randomized controlled trials (RCTs) investigating the effect of RFA in combination with chemotherapy in patients with LAPC are lacking.
METHODS
The "Pancreatic Locally Advanced Unresectable Cancer Ablation" (PELICAN) trial is an international multicenter superiority RCT, initiated by the Dutch Pancreatic Cancer Group (DPCG). All patients with LAPC according to DPCG criteria, who start with FOLFIRINOX or (nab-paclitaxel/)gemcitabine, are screened for eligibility. Restaging is performed after completion of four cycles of FOLFIRINOX or two cycles of (nab-paclitaxel/)gemcitabine (i.e., 2 months of treatment), and the results are assessed within a nationwide online expert panel. Eligible patients with RECIST stable disease or objective response, in whom resection is not feasible, are randomized to RFA followed by chemotherapy or chemotherapy alone. In total, 228 patients will be included in 16 centers in The Netherlands and four other European centers. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, RECIST response, CA 19.9 and CEA response, toxicity, quality of life, pain, costs, and immunomodulatory effects of RFA.
DISCUSSION
The PELICAN RCT aims to assess whether the combination of chemotherapy and RFA improves the overall survival when compared to chemotherapy alone, in patients with LAPC with no progression of disease following 2 months of systemic treatment.
TRIAL REGISTRATION
Dutch Trial Registry NL4997 . Registered on December 29, 2015. ClinicalTrials.gov NCT03690323 . Retrospectively registered on October 1, 2018.
背景
约80%的局部晚期胰腺癌（LAPC）患者接受化疗，其中约10%接受手术切除。队列研究表明，在多模式治疗中，射频消融（RFA）局部肿瘤消融的总生存期可达26 - 34个月，前景良好。然而，目前缺乏关于RFA联合化疗对LAPC患者疗效的随机对照试验（RCT）。
方法
“胰腺癌局部晚期不可切除癌消融”（PELICAN）试验是一项由荷兰胰腺癌研究组（DPCG）发起的国际多中心优效性RCT。所有符合DPCG标准、开始接受FOLFIRINOX或（白蛋白结合型紫杉醇/）吉西他滨治疗的LAPC患者均进行资格筛查。在完成4个周期的FOLFIRINOX或2个周期的（白蛋白结合型紫杉醇/）吉西他滨（即2个月治疗）后进行重新分期，并在全国在线专家小组内评估结果。符合条件的、疾病稳定或有客观缓解且无法进行手术切除的患者，随机分为RFA联合化疗组或单纯化疗组。荷兰的16个中心和其他4个欧洲中心共纳入228例患者。主要终点是总生存期。次要终点包括无进展生存期、RECIST反应、CA 19.9和CEA反应、毒性、生活质量、疼痛、成本以及RFA的免疫调节作用。
讨论
PELICAN RCT旨在评估在接受2个月系统治疗后疾病无进展的LAPC患者中，与单纯化疗相比，化疗联合RFA是否能提高总生存期。
试验注册
荷兰试验注册中心NL4997。于2015年12月29日注册。ClinicalTrials.gov NCT03690323。于2018年10月1日追溯注册。
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