Removing enlarged cardiophrenic lymph nodes during surgery for advanced ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm, single-center study using a historical control group to compare outcomes with and without cardiophrenic lymph node (CPLN) resection. Patients with stage III/IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who have small enlarged CPLNs will undergo CPLN enucleation at the time of cytoreductive surgery. The primary comparison is median recurrence-free survival (mRFS), with documentation of perioperative safety, postoperative overall survival, quality of life changes, and technical feasibility. The planned sample size is 52 patients in the CPLN resection group and 52 in the historical control group, and the trial is conducted at the First Hospital of Jilin University in Changchun, Jilin.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• the first hospital of JILIN UNIVERSITY
  Changchun, Jilin, China Recruiting

Study contacts

• Study coordinator: Li XIAOSEN
• Email: xiaosen4019@163.com
• Phone: +8618343116682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.