Application of Cardiophrenic Lymphadenectomy in Advanced Ovarian Cancer: A Single-Center Prospective Exploratory Study

Обзор

The aim of this study is to investigate the efficacy and safety of enucleation of enlarged CPLNs in patients with advanced ovarian cancer.

Подробное описание

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.

Вмешательства

• Процедура CPLN resection
  Diaphragmatic angle lymph node dissection

Первичные конечные точки

• RFS [Срок оценки: experimental group 17.2 month]
• Recurrence-free survival (RFS) [Срок оценки: 9-17 month]

Критерии участия

Критерии включения

• 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; 2. Residual intra-abdominal tumour measuring ≤ 1 cm following cytoreductive surgery; 3. Women aged 18-70 years who are not pregnant or breastfeeding; 4. ECOG performance status of 0 or 1; 5. 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; 6. Expected survival ≥ 6 months; 7. The patient fully understands this study, consents to CPLN resection, voluntarily participates in this clinical trial and has signed the informed consent form.

Критерии исключения

• 1\. Stage I or II epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer; 2. Residual intra-abdominal tumour > 1 cm following cytoreductive surgery; 3. Imaging showing CPLNs with a short axis > 1 cm; 4. Imaging evidence of mediastinal lymph node metastasis outside the CPLNs; 5. 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); 6. 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); 7. Any unstable condition or circumstance that may compromise patient safety or compliance; 8. Currently receiving treatment with other anticancer drugs; 9. Refusal to sign the informed consent form.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the first hospital of JILIN UNIVERSITY — Changchun

Идентификаторы

NCT: NCT07572409 · 25K279-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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