Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer

NCT05236686 | Recruiting

• 1 other identifier: zsfud-GynOncol-005
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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-sensitive recurrent ovarian cancer.

Conditions

Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Keywords

Ovarian Cancer; Surgery; Lymph Node Metastasis; Hepato-celiac Lymphadenectomy

Outcome Measures

Primary Outcomes (1)

• 2-years Non-Progression Rate

  The proportion of patients without disease progression or death at 2 years after entry into the study.

  Participants will be followed up to 2 years after randomization

Secondary Outcomes (8)

• Progression free survival

  Participants will be followed up to 24 months after randomization

• Overall survival

  Participants will be followed up to 60 months after randomization

• Objective response rate

  Participants will be followed up to 24 months after randomization

• Disease control rate

  Participants will be followed up to 24 months after randomization

• Post-operative complications

  Participants will be followed up to 90 days after randomization

Study Arms (1)

Hepato-celiac lymphadenectomy

EXPERIMENTAL

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, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).

Procedure: Hepato-celiac lymphadenectomy

Interventions

Hepato-celiac lymphadenectomy PROCEDURE

Hepato-celiac lymphadenectomy in the treatment of epithelial ovarian cancer, with a maximum cytoreduction, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).

Hepato-celiac lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Gynecologic Oncology Group: lead
• Fudan University: collaborator

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Ovarian Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rongyu Zang

  Fudan University

  STUDY CHAIR

Central Study Contacts

Libing Xiang

CONTACT

862164041990; xiang.libing@zs-hospital.sh.cn

Rong Jiang

CONTACT

86 21 64041990; jiang.rong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 11, 2022
• Study Start: February 15, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)