Application of Cardiophrenic Lymphadenectomy in Advanced Ovarian Cancer: A Single-Center Prospective Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
研究概览
简要总结
The aim of this study is to investigate the efficacy and safety of enucleation of enlarged CPLNs in patients with advanced ovarian cancer.
详细描述
This is an open-label, single-arm, single-centre clinical trial with a historical control design, designed to assess the difference in median recurrence-free survival (mRFS) between patients with stage III/IV cutaneous ovarian cancer, fallopian tube cancer or primary peritoneal cancer who undergo CPLNs resection and those who do not. The required sample size for the historical control group is 52 patients, and the required sample size for the CPLN resection group is also 52 patients. The study will assess the impact of CPLN resection on recurrence, whilst documenting perioperative safety, observing postoperative overall survival (OS) and changes in patients' postoperative quality of life, and finally analysing technical feasibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •1. Patients with stage III or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, where imaging indicates enlarged CPLNs (short axis ≥ 5 mm and/or PET-CT positive) and the short axis is ≤ 1 cm;
- •Residual intra-abdominal tumour measuring ≤ 1 cm following cytoreductive surgery;
- •Women aged 18-70 years who are not pregnant or breastfeeding;
- •ECOG performance status of 0 or 1;
- •Adequate organ function: white blood cell count ≥2.5×10⁹/L and neutrophil count ≥1.5×10⁹/L, haemoglobin ≥ 90 g/L, platelets ≥ 100 × 10⁹/L; serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal, aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; serum creatinine ≤ 1.5 times the normal value, creatinine clearance ≥ 60 ml/min;
- •Expected survival ≥ 6 months;
- •The patient fully understands this study, consents to CPLN resection, voluntarily participates in this clinical trial and has signed the informed consent form.
排除标准
- •1. Stage I or II epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer;
- •Residual intra-abdominal tumour > 1 cm following cytoreductive surgery;
- •Imaging showing CPLNs with a short axis > 1 cm;
- •Imaging evidence of mediastinal lymph node metastasis outside the CPLNs;
- •Presence of other active malignant tumours within the past 5 years. Excludes locally cured tumours (e.g. basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or in situ breast cancer);
- •Concurrent presence of other severe, uncontrollable medical conditions (including atrial fibrillation, angina pectoris, heart failure, ejection fraction <50%, uncontrolled hypertension, renal insufficiency, or uncontrolled infections);
- •Any unstable condition or circumstance that may compromise patient safety or compliance;
- •Currently receiving treatment with other anticancer drugs;
- •Refusal to sign the informed consent form.
研究者
manxiaxia
Professor
The First Hospital of Jilin University