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

A Prospective, Single-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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fallopian Tube Cancer; Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma
• Intervention / Treatment: Procedure: Hepato-celiac lymphadenectomy

Detailed Description

This single-arm, single-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).

• Study Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Libing Xiang; Phone Number: 2801 862164041990; Email: xiang.libing@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China
    • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Hepato-celiac lymphadenectomy; This single-arm, single-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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first	Participants will be followed up to 24 months after randomization
Overall survival	The time from date of randomization until the date of death from any cause or last follow-up	Participants will be followed up to 60 months after randomization
Objective response rate	The proportion of patients who achieved complete response (CR) or partial response (PR)	Participants will be followed up to 24 months after randomization
Disease control rate	The proportion of patients who achieved complete response (CR) or partial response (PR) or stable disease (SD)	Participants will be followed up to 24 months after randomization
Post-operative complications	Postoperative 30-day, 60-day and 90-day complications	Participants will be followed up to 90 days after randomization
Quality of life assessments (QLQ-C30)	Assessment of potential impact of first line treatment on functionality and well-being in patients by the EORTC core quality of life questionnaire (QLQ-C30, version 3.0).	Baseline; 6 months, 12 months and 24 months after randomization
Quality of life assessments (FACT-Q)	Assessment of potential impact of first line treatment on functionality and well-being in patients by functional assessment of cancer therapy-ovary (FACT-O, version 4).	Baseline; 6 months, 12 months and 24 months after randomization
Patterns of subsequent recurrence	The number and sites of subsequent recurrence, including pelvic, abdominal, retroperitoneal lymph nodes, hepato-celiac lymph nodes and distant metastases and ascites, etc.	Participants will be followed up to 24 months after randomization

Collaborators and Investigators

• Sponsor: Shanghai Gynecologic Oncology Group
• Collaborators: Fudan University
• Investigators: Study Chair: Rongyu Zang, Fudan University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2025
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (ACTUAL): February 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Surgery; Ovarian Cancer; Lymph Node Metastasis; Hepato-celiac Lymphadenectomy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: zsfud-GynOncol-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No