GECOP-MMC：一项评估在结直肠癌腹膜转移患者完全手术细胞减灭术后应用丝裂霉素 C 行腹腔热灌注化疗（HIPEC）的疗效的 IV 期随机临床试验。
GECOP-MMC: phase IV randomized clinical trial to evaluate the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) with mytomicin-C after complete surgical cytoreduction in patients with colon cancer peritoneal metastases.
机构信息
Hospital Universitario de Fuenlabrada, Camino del Molino 2, Fuenlabrada, 28942, Madrid, Spain.
MD Anderson Cancer Center, Calle de Arturo Soria 270, 28033, Madrid, Spain.
出版信息
BMC Cancer. 2022 May 12;22(1):536. doi: 10.1186/s12885-022-09572-7.
BACKGROUND
The French PRODIGE 7 trial, published on January 2021, has raised doubts about the specific survival benefit provided by HIPEC with oxaliplatin 460 mg/m (30 minutes) for the treatment of peritoneal metastases from colorectal cancer. However, several methodological flaws have been identified in PRODIGE 7, specially the HIPEC protocol or the choice of overall survival as the main endpoint, so its results have not been assumed as definitive, emphasizing the need for further research on HIPEC. It seems that the HIPEC protocol with high-dose mytomicin-C (35 mg/m) is the preferred regime to evaluate in future clinical studies.
METHODS
GECOP-MMC is a prospective, open-label, randomized, multicenter phase IV clinical trial that aims to evaluate the effectiveness of HIPEC with high-dose mytomicin-C in preventing the development of peritoneal recurrence in patients with limited peritoneal metastasis from colon cancer (not rectal), after complete surgical cytoreduction. This study will be performed in 31 Spanish HIPEC centres, starting in March 2022. Additional international recruiting centres are under consideration. Two hundred sixteen patients with PCI ≤ 20, in which complete cytoreduction (CCS 0) has been obtained, will be randomized intraoperatively to arm 1 (with HIPEC) or arm 2 (without HIPEC). We will stratified randomization by surgical PCI (1-10; 11-15; 16-20). Patients in both arms will be treated with personalized systemic chemotherapy. Primary endpoint is peritoneal recurrence-free survival at 3 years. An ancillary study will evaluate the correlation between surgical and pathological PCI, comparing their respective prognostic values.
DISCUSSION
HIPEC with high-dose mytomicin-C, in patients with limited (PCI ≤ 20) and completely resected (CCS 0) peritoneal metastases, is assumed to reduce the expected risk of peritoneal recurrence from 50 to 30% at 3 years.
TRIAL REGISTRATION
EudraCT number: 2019-004679-37; Clinicaltrials.gov: NCT05250648 (registration date 02/22/2022, ).
背景
法国 PRODIGE 7 试验于 2021 年 1 月公布，该试验对奥沙利铂 460mg/m（30 分钟）行 HIPEC 治疗结直肠癌腹膜转移的特定生存获益提出了质疑。然而，PRODIGE 7 存在一些方法学缺陷，特别是 HIPEC 方案或选择总生存作为主要终点，因此其结果并未被认为是明确的，强调需要进一步研究 HIPEC。似乎高剂量丝裂霉素 C（35mg/m）的 HIPEC 方案是未来临床研究中首选的评估方案。
方法
GECOP-MMC 是一项前瞻性、开放标签、随机、多中心的 IV 期临床试验，旨在评估高剂量丝裂霉素 C 行 HIPEC 预防结直肠癌（非直肠）局限性腹膜转移患者腹膜复发的有效性，这些患者在完全手术减瘤后获得完全缓解（CCS 0）。这项研究将于 2022 年 3 月在 31 个西班牙 HIPEC 中心进行，同时正在考虑其他国际招募中心。将 216 名 PCI≤20、获得完全肿瘤细胞减灭术（CCS 0）的患者术中随机分为 1 组（HIPEC 组）或 2 组（无 HIPEC 组）。我们将根据手术 PCI（1-10；11-15；16-20）进行分层随机化。两组患者均接受个性化全身化疗。主要终点是 3 年时的腹膜无复发生存率。一项辅助研究将评估手术 PCI 和病理 PCI 之间的相关性，比较它们各自的预后价值。
讨论
对于局限性（PCI≤20）和完全切除（CCS 0）的腹膜转移患者，高剂量丝裂霉素 C 行 HIPEC 被认为可将 3 年时腹膜复发的预期风险从 50%降低至 30%。
试验注册
EudraCT 编号：2019-004679-37；Clinicaltrials.gov：NCT05250648（注册日期 2022 年 2 月 22 日）。
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