NCT00712218已完成不适用
Randomized, Multicentre Trial for Lymphadenectomy In Ovarian Neoplasms
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 640
- 试验地点
- 117
- 主要终点
- Overall Survival
研究概览
简要总结
To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking.
Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of invasive epithelial ovarian cancer FIGO stage IIB-IV (IV only if resectable metastasis in pleura, liver, spleen, and/or abdominal wall)
- •Macroscopic complete resection
- •Age: 18 - 75 years
- •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
- •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.
- •Recurrent ovarian cancer
- •Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy
- •Diseases of the lymph system (including lymph edema of unknown origin)
- •Clinical relevant dysfunctions of blood clotting (including medicamentous conditioned reasons, e.g. ASS, if not stopped at least 7 days prior to surgery)
- •Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)
- •Prior retroperitoneal lymph node dissection (systematic or sampling)
- •Pregnancy
- •Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
- •Any reasons interfering with regular follow-up
结局指标
主要结局
Overall Survival
时间窗: time from randomization until death
次要结局
- - Progression-free survival (PFS) - Quality of life (QoL) as measured by EORTC QLQ-C30, OV28 - number of resected lymph nodes(Progression-free survival time is calculated from the date of surgery until the date of first progressive disease or death, whichever occurs first or date of last contact (censored observation).)
研究者
Ursula Ghulami
KKS Marburg sponsor representative
Philipps University Marburg
研究点 (117)
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