Status:
RECRUITING
Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer
Lead Sponsor:
Shanghai Gynecologic Oncology Group
Collaborating Sponsors:
Fudan University
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and the effectiveness of hepato-celiac lymphadenectomy in the treatment of primarily diagnosed advanced epithelial ovarian cancer and platinum-sensi...
Detailed Description
This single-arm, multi-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases,...
Eligibility Criteria
Inclusion
- Age ≥18 years to ≤ 75 years.
- Pathologic confirmed stage III or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (EOC, PPC, FTC) or platinum sensitive, relapsed EOC, PPC or FTC (no more than 4 lines of therapy)
- Hepato-celiac lymph nodes metastases diagnosed by imaging before surgery and enlarged palpable lymph nodes by surgical findings
- Assessed by the experienced surgeons, complete resection is feasible according to preoperative evaluation
- 1 to 3 episodes of neoadjuvant chemotherapy is allowed in primary settings
- Platinum sensitive relapse is defined as those with platinum-free interval of 6 months or more.
- ASA score of 1 to 2
- ECOG performance status of 0 to 2
- Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
- White blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
- Serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockcroft-Gault formula or to local lab measurement
- Serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL
- Comply with the study protocol and follow-up.
- Written informed consent.
Exclusion
- Patients with non-epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
- Low-grade carcinoma.
- Mucinous ovarian cancer.
- Infeasible complete resection according to preoperative evaluation
- Unresectable pulmonary and hepatic parenchymal metastases, multiple thoracic lymph nodes metastases, brain or bone metastases according to preoperative evaluation.
- Carcinomatosis on small bowel mesentery or intestinal wall by surgical findings and infeasible optimal surgery by bowel resection or peritonectomy.
- Progression after neoadjuvant chemotherapy in primary settings.
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity).
- Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
- Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT05236686
Start Date
February 15 2022
End Date
December 1 2025
Last Update
November 19 2025
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, China