Huiskens Joost, van Gulik Thomas M, van Lienden Krijn P, Engelbrecht Marc R W, Meijer Gerrit A, van Grieken Nicole C T, Schriek Jonne, Keijser Astrid, Mol Linda, Molenaar I Quintus, Verhoef Cornelis, de Jong Koert P, Dejong Kees H C, Kazemier Geert, Ruers Theo M, de Wilt Johanus H W, van Tinteren Harm, Punt Cornelis J A
Department of Surgery, Academic Medical Centre, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Department of Medical Oncology, Academic Medical Centre, Amsterdam, the Netherlands.
BMC Cancer. 2015 May 6;15:365. doi: 10.1186/s12885-015-1323-9.
Colorectal cancer patients with unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and the lack of consensus on criteria for (un)resectability complicates the interpretation of published results.
METHODS/DESIGN: CAIRO5 is a multicentre, randomised, phase 3 clinical study. Colorectal cancer patients with initially unresectable liver-only metastases are eligible, and will not be selected for potential resectability. The (un)resectability status is prospectively assessed by a central panel consisting of at least one radiologist and three liver surgeons, according to predefined criteria. Tumours of included patients will be tested for RAS mutation status. Patients with RAS wild type tumours will be treated with doublet chemotherapy (FOLFOX or FOLFIRI) and randomised between the addition of either bevacizumab or panitumumab, and patients with RAS mutant tumours will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab or triple chemotherapy (FOLFOXIRI) plus bevacizumab. Radiological evaluation to assess conversion to resectability will be performed by the central panel, at an interval of two months. The primary study endpoint is median progression-free survival. Secondary endpoints are the R0/1 resection rate, median overall survival, response rate, toxicity, pathological response of resected lesions, postoperative morbidity, and correlation of baseline and follow-up evaluation with respect to outcomes by the central panel.
CAIRO5 is a prospective multicentre trial that investigates the optimal systemic induction therapy for patients with initially unresectable, liver-only colorectal cancer metastases.
CAIRO 5 is registered at European Clinical Trials Database (EudraCT) (2013-005435-24). CAIRO 5 is registered at ClinicalTrials.gov: NCT02162563 , June 10, 2014.
仅发生肝转移且无法切除的结直肠癌患者，在通过新辅助全身治疗使转移灶缩小后有可能治愈。然而，最佳的新辅助诱导方案尚未确定，并且对于（不可）切除标准缺乏共识使得已发表结果的解读变得复杂。
方法/设计：CAIRO5是一项多中心、随机、3期临床研究。最初仅发生无法切除的肝转移的结直肠癌患者符合条件，且不会根据潜在的可切除性进行选择。由至少一名放射科医生和三名肝脏外科医生组成的中央小组将根据预定义标准对（不可）切除状态进行前瞻性评估。纳入患者的肿瘤将检测RAS突变状态。RAS野生型肿瘤患者将接受双药化疗（FOLFOX或FOLFIRI），并随机分组接受贝伐单抗或帕尼单抗，RAS突变型肿瘤患者将在双药化疗（FOLFOX或FOLFIRI）加贝伐单抗与三药化疗（FOLFOXIRI）加贝伐单抗之间随机分组。中央小组将每隔两个月进行一次放射学评估以评估是否转化为可切除。主要研究终点是无进展生存期的中位数。次要终点包括R0/1切除率、总生存期的中位数、缓解率、毒性、切除病灶的病理反应、术后发病率，以及中央小组对基线和随访评估与结果之间的相关性。
CAIRO5是一项前瞻性多中心试验，旨在研究最初仅发生无法切除的肝转移的结直肠癌患者的最佳全身诱导治疗。
CAIRO 5已在欧洲临床试验数据库（EudraCT）注册（2013 - 005435 - 24）。CAIRO 5已在ClinicalTrials.gov注册：NCT02162563，2014年6月10日。
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