Removing enlarged cardiophrenic lymph nodes during surgery for advanced ovarian cancer

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

This will try removing enlarged cardiophrenic lymph nodes during surgery in women with advanced ovarian, fallopian tube, or primary peritoneal cancer to see if it delays cancer coming back and is safe.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT07572409 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women aged 18–70 with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer who have imaging evidence of enlarged CPLNs (short axis ≥5 mm and ≤1 cm or PET-CT positive), residual intra-abdominal tumor ≤1 cm after cytoreduction, ECOG 0–1, and adequate organ function are the ideal candidates.

Not a fit: Patients without enlarged CPLNs, with CPLNs larger than 1 cm, with extensive residual intra-abdominal disease, poor performance status, significant comorbidities, or who are pregnant or breastfeeding are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, removing involved cardiophrenic nodes could prolong the time before cancer returns and might improve long-term outcomes for selected patients.

How similar studies have performed: Some retrospective case series and small surgical reports have suggested potential benefit from cardiophrenic lymph node removal, but randomized or large prospective evidence is limited and this approach remains relatively novel in prospective testing.

Eligibility criteria

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 this trial is running

Changchun, Jilin

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

Study contacts

• Study coordinator: Li XIAOSEN

Conditions Ovarian Cancer