原发性细胞减灭术联合或不联合腹腔热灌注化疗（HIPEC）治疗国际妇产科联盟（FIGO）分期 III 期上皮性卵巢癌：OVHIPEC-2，一项 III 期随机临床试验。
Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial.
机构信息
Department of Gynaecology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
出版信息
Int J Gynecol Cancer. 2020 Jun;30(6):888-892. doi: 10.1136/ijgc-2020-001231. Epub 2020 Mar 23.
BACKGROUND
The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery. The effect of HIPEC remains undetermined in patients who are candidates for primary cytoreductive surgery.
PRIMARY OBJECTIVE
The primary objective is to evaluate the effect of HIPEC on overall survival in patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm in maximum dimension.
STUDY HYPOTHESIS
We hypothesize that the addition of HIPEC to primary cytoreductive surgery improves overall survival in patients with primary FIGO stage III epithelial ovarian cancer.
TRIAL DESIGN
This international, randomized, open-label, phase III trial will enroll 538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer. Following complete or near-complete (residual disease ≤2.5 mm) primary cytoreduction, patients are randomly allocated (1:1) to receive HIPEC or no HIPEC. All patients will receive six courses of platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab according to current guidelines.
MAJOR ELIGIBILITY CRITERIA
Patients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery. Patients with resectable umbilical, spleen, or local bowel lesions may be included. Enlarged extra-abdominal lymph nodes should be negative on FDG-PET or fine-needle aspiration/biopsy.
PRIMARY ENDPOINT
The primary endpoint is overall survival.
SAMPLE SIZE
To detect a HR of 0.67 in favor of HIPEC, 200 overall survival events are required. With an expected accrual period of 60 months and 12 months additional follow-up, 538 patients need to be randomized.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
The OVHIPEC-2 trial started in January 2020 and primary analyses are anticipated in 2026.
TRIAL REGISTRATION
ClinicalTrials.gov:NCT03772028.
背景
对于不适合初次细胞减灭术的国际妇产科联合会（FIGO）分期 III 卵巢癌患者，添加腹腔内热化疗（HIPEC）可提高无复发生存率和总生存率。在适合初次细胞减灭术的患者中，HIPEC 的效果仍不确定。
主要目的
主要目的是评估 HIPEC 对接受初次细胞减灭术且无残留疾病或最大残留直径达 2.5mm 以内残留疾病的 FIGO 分期 III 上皮性卵巢癌患者总生存率的影响。
研究假设
我们假设 HIPEC 联合初次细胞减灭术可改善原发性 FIGO 分期 III 上皮性卵巢癌患者的总生存率。
试验设计
这是一项国际性、随机、开放标签、III 期临床试验，将纳入 538 例新诊断为 FIGO 分期 III 上皮性卵巢癌的患者。在完成或接近完全（残留疾病≤2.5mm）初次细胞减灭术后，患者按 1:1 随机分配接受 HIPEC 或不接受 HIPEC。所有患者将接受 6 个疗程的铂类紫杉醇化疗，并根据现行指南接受维持 PARP 抑制剂或贝伐珠单抗治疗。
主要入选标准
FIGO 分期 III 期原发性卵巢癌、输卵管癌或原发性腹膜癌患者，在完成或接近完全初次细胞减灭术后有资格入组。可包括可切除的脐部、脾脏或局部肠病变。FDG-PET 或细针抽吸/活检阴性的增大的腹外淋巴结。
主要终点
总生存率。
样本量
为了检测 HIPEC 有利的 HR 为 0.67，需要 200 例总生存事件。预计入组期为 60 个月，额外随访 12 个月，需要随机分配 538 例患者。
预计完成入组和呈现结果的日期
OVHIPEC-2 试验于 2020 年 1 月开始，预计在 2026 年进行主要分析。
试验注册
ClinicalTrials.gov：NCT03772028。
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