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

Shanghai Gynecologic Oncology Group

Status

Enrolling

Conditions

Epithelial Ovarian Cancer

Primary Peritoneal Carcinoma

Fallopian Tube Cancer

Treatments

Procedure: Hepato-celiac lymphadenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05236686

zsfud-GynOncol-005

Details and patient eligibility

About

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.

Full 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, 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).

Enrollment

94 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.