Obstetrics and Gynecology Hospital, Fudan University, 128 Shenyang Rd 200090, Shanghai, China.
Shanghai Jiao Tong University School of Medicine, Renji Hospital, Shanghai, China.
Trials. 2023 Aug 18;24(1):542. doi: 10.1186/s13063-023-07573-w.
Cervical cancer is and will remain to be an important health problem in China, especially with an increasing proportion of younger patients who has more specific needs. In China, surgery to remove tumor burden followed by postoperative treatment with radiotherapy and chemotherapy based on clinicopathologic factors may be the best choice for stages IB3 and IIA2 patients. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology. The current trial is designed to evaluate whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB3 and IIA2) patient survival under stringent operation standards and consistent surgical oncologic principles. This paper reports the rationale, design, and implementation of the trial.
METHODS/DESIGN: This is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 1104 patients with stage IB3 and IIA2 cervical cancer will be enrolled over a period of 3 years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed up for at least 5 years. The primary end point will be 5-year overall survival, and secondary endpoints include 5-year progression-free survival, recurrence, and quality of life measurements.
The study results will provide more convincing evidence-based information for stages IB3 and IIA2 cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method.
ClinicalTrials.gov, NCT04939831 , retrospectively registered on 25 June 2021.
宫颈癌仍然是中国一个重要的健康问题，尤其是年轻患者比例不断增加，他们有更特殊的需求。在中国，对于 IB3 期和 IIA2 期的患者，手术切除肿瘤负荷，然后根据临床病理因素进行术后放疗和化疗，可能是最佳选择。宫颈癌根治性子宫切除术一直是妇科的经典标志性手术。本试验旨在评估在严格的手术标准和一致的外科肿瘤学原则下，腹腔镜 RH 与开腹 RH 在宫颈癌（IB3 期和 IIA2 期）患者生存方面是否存在差异。本文报告了试验的原理、设计和实施情况。
方法/设计：这是一项由研究者发起的、前瞻性的、随机的、开放性的、终点设盲（PROBE）的对照试验。将在 3 年内共纳入 1104 例 IB3 期和 IIA2 期宫颈癌患者。患者按照 1:1 随机分为腹腔镜 RH 组或开腹 RH 组。然后对患者进行至少 5 年的随访。主要终点为 5 年总生存率，次要终点包括 5 年无进展生存率、复发率和生活质量测量。
研究结果将为 IB3 期和 IIA2 期宫颈癌患者及其妇科肿瘤外科医生在选择手术方法时提供更有说服力的循证信息。
ClinicalTrials.gov，NCT04939831，于 2021 年 6 月 25 日进行了回顾性注册。
