A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 656
- 试验地点
- 1
- 主要终点
- PFS(Progression-free survival)
研究概览
简要总结
To assess the impact of comprehensive staging surgery with no lymphadenectomy on survival and quality of life in patients with early-stage ovarian cancer.
详细描述
OBJECTIVES: Compare the efficacy and safety in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA -IIA epithelial ovarian cancer, undergo completion staging surgery including systematic pelvic and para-aortic lymphadenectomy versus comprehensive staging surgery without lymphadenectomy.
OUTLINE: This is a randomized phase III multicenter study. Patients will receive comprehensive staging surgery without Lymphadenectomy or completion staging surgery including systematic pelvic and para-aortic lymphadenectomy, and the adjuvant chemotherapy will accord to National Comprehensive Cancer Network (NCCN) guidelines. Patients are followed up every 3 months within the first 2 years, and then every 6 months.
PROJECTED ACCRUAL: A total of 656 patients will be recruited for this study within 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years to 70 years.
- •Primary diagnosis of epithelial ovarian cancer FIGO stage IA-IIA ( recevive no prior treatment or receive incomplete initial surgery)，with indications of adjuvant chemotherapy：①High-grade serous carcinoma; ②Grade 3 endometrioid carcinoma; ③Clear cell carcinoma; ④Grade 2 endometrioid carcinoma with capsule ruptured or pelvic tissues extension ⑤Low-grade serous carcinoma、Grade 1 endometrioid carcinoma and Mucinous carcinoma of the ovary with pelvic tissues extension.
- •Patients who have given their signed and written informed consent.
- •Good performance status (ECOG 0/1).
排除标准
- •Non epithelial ovarian malignancies and borderline tumors.
- •Suspicious lymph nodes at preoperative radiological evaluation.
- •Intraoperative clinically suspicious lymph nodes (bulky nodes).
- •Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.
- •Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
- •Diseases of the lymph system (including lymph edema of unknown origin).
- •Prior retroperitoneal lymph node dissection (systematic or sampling).
- •Any other concurrent medical conditions contraindicating surgery.
- •Any reasons interfering with giving of informed consent , abiding by protocol, or regular follow-up.
结局指标
主要结局
PFS(Progression-free survival)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
次要结局
- QoL(Quality of life)(Baseline, 6 months and 1 year after surgery)
- Recurrence rate of lymph node(3 years)
- OS(Overall Survival)(From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons)
- Postoperative complications(3 years)
研究者
Jihong Liu
Professor
Sun Yat-sen University