A Prospective, Multi-center, Single-Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Hepato-celiac Lymphadenectomy in the Treatment of Advanced and Recurrent Ovarian Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Libing Xiang
xiang.libing@zs-hospital.sh.cn
862164041990
Backup
Rong Jiang
jiang.rong@zs-hospital.sh.cn
86 21 64041990
Time Frame
Start Date: 2022-02-15
Estimated Completion Date: 2025-12
Participants
Target number of participants: 94
Treatments
Experimental: Hepato-celiac lymphadenectomy
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).
Related Therapeutic Areas
Sponsors
Leads: Shanghai Gynecologic Oncology Group
Collaborators: Fudan University

This content was sourced from clinicaltrials.gov