Janda M, Gebski V, Forder P, Jackson D, Williams G, Obermair A
Queensland University of Technology, Centre for Health Research-Public Health, Kelvin Grove, Brisbane, Queensland, Australia.
Contemp Clin Trials. 2006 Aug;27(4):353-63. doi: 10.1016/j.cct.2006.03.004. Epub 2006 May 5.
Endometrial cancer is the most common gynaecological malignancy in Australia and the US. Current standard treatment involves open surgery to remove the uterus, and both tubes and ovaries (TAH). The Laparoscopic Approach to Cancer of the Endometrium (LACE) trial was designed to assess equivalence of performing this in a total laparoscopic approach (TLH).
Patient recruitment was designed to proceed along two stages to accommodate for a potential increase in patient requests of laparoscopic surgery. During the first stage, patients are randomised in a 2:1 allocation to receive TLH or TAH, with the primary endpoint quality of life (QoL) at 6 month post-surgery, requiring 180 patients to be enrolled to have 80% power at alpha=0.05 to detect a clinically significant difference of 8 points on the Functional Assessment of Cancer General (FACT-G) QoL instrument. If additional recruitment of patients seems impossible after accrual of 180 patients, this cohort will be followed for 4 years, and disease free survival (DFS) of patients treated by TLH will be compared to DFS within the endometrial cancer population. During the second stage, recruitment will be extended to a total of 590 patients in a 1:1 TLH:TAH allocation, to assess the equivalence with respect to DFS with 80% power and alpha=0.05. Equivalence will be assumed if the difference in DFS does not exceed 7% at 4 years. Secondary outcomes include treatment related morbidity; costs and cost-effectiveness; patterns of recurrence; and overall survival. All data from this multicentre study will be entered using online electronic case report forms (e-CRF), allowing real time assessment of data completeness and patient follow-up.
The LACE trial will establish the equivalence of a TLH approach for patients with stage 1 endometrial cancer following a two stage protocol to accommodate potential threats to patient recruitment through requests for laparoscopic surgery.
子宫内膜癌是澳大利亚和美国最常见的妇科恶性肿瘤。当前的标准治疗方法是通过开放性手术切除子宫、双侧输卵管和卵巢（全子宫切除术）。子宫内膜癌腹腔镜手术方法（LACE）试验旨在评估全腹腔镜手术（TLH）在治疗子宫内膜癌方面的等效性。
患者招募分两个阶段进行，以应对患者对腹腔镜手术需求可能增加的情况。在第一阶段，患者按2:1的比例随机分配接受TLH或全子宫切除术，主要终点是术后6个月的生活质量（QoL），需要招募180名患者，以在α=0.05时具有80%的检验效能，检测癌症通用功能评估（FACT-G）QoL工具上8分的临床显著差异。如果在招募180名患者后似乎无法再额外招募患者，将对该队列进行4年随访，并将接受TLH治疗的患者的无病生存期（DFS）与子宫内膜癌人群中的DFS进行比较。在第二阶段，招募将扩展至共590名患者，按1:1的比例分配接受TLH或全子宫切除术，以评估在DFS方面的等效性，检验效能为80%，α=0.05。如果4年时DFS的差异不超过7%，则认为具有等效性。次要结局包括治疗相关的发病率；成本和成本效益；复发模式；以及总生存期。这项多中心研究的所有数据将使用在线电子病例报告表（e-CRF）录入，以便实时评估数据完整性和患者随访情况。
LACE试验将通过两阶段方案确定TLH方法对I期子宫内膜癌患者的等效性，以应对因患者对腹腔镜手术的需求而对患者招募造成的潜在威胁。
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