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

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Hepato-celiac lymphadenectomy

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Ovarian Cancer, Surgery, Lymph Node Metastasis, Hepato-celiac Lymphadenectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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)
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.

Sites / Locations

Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hepato-celiac lymphadenectomy

Arm 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).

Outcomes

Primary Outcome Measures

2-years Non-Progression Rate

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

Secondary Outcome Measures

Progression free survival

The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first

Overall survival

The time from date of randomization until the date of death from any cause or last follow-up

Objective response rate

The proportion of patients who achieved complete response (CR) or partial response (PR)

Disease control rate

The proportion of patients who achieved complete response (CR) or partial response (PR) or stable disease (SD)

Post-operative complications

Postoperative 30-day, 60-day and 90-day complications

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).

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).

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.

Full Information

NCT ID

NCT05236686

First Posted

January 28, 2022

Last Updated

February 9, 2022

Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT05236686

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 2022 (Anticipated)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hepato-celiac lymphadenectomy

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Hepato-celiac lymphadenectomy

Intervention Description

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).

Primary Outcome Measure Information:

Title

2-years Non-Progression Rate

Description

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

Time Frame

Participants will be followed up to 2 years after randomization

Secondary Outcome Measure Information:

Title

Progression free survival

Description

The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first

Time Frame

Participants will be followed up to 24 months after randomization

Title

Overall survival

Description

The time from date of randomization until the date of death from any cause or last follow-up

Time Frame

Participants will be followed up to 60 months after randomization

Title

Objective response rate

Description

The proportion of patients who achieved complete response (CR) or partial response (PR)

Time Frame

Participants will be followed up to 24 months after randomization

Title

Disease control rate

Description

The proportion of patients who achieved complete response (CR) or partial response (PR) or stable disease (SD)

Time Frame

Participants will be followed up to 24 months after randomization

Title

Post-operative complications

Description

Postoperative 30-day, 60-day and 90-day complications

Time Frame

Participants will be followed up to 90 days after randomization

Title

Quality of life assessments (QLQ-C30)

Description

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).

Time Frame

Baseline; 6 months, 12 months and 24 months after randomization

Title

Quality of life assessments (FACT-Q)

Description

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).

Time Frame

Baseline; 6 months, 12 months and 24 months after randomization

Title

Patterns of subsequent recurrence

Description

The number and sites of subsequent recurrence, including pelvic, abdominal, retroperitoneal lymph nodes, hepato-celiac lymph nodes and distant metastases and ascites, etc.

Time Frame

Participants will be followed up to 24 months after randomization

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Libing Xiang

Phone

862164041990

Ext

2801

xiang.libing@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Rong Jiang

Phone

86 21 64041990

Ext

2801

jiang.rong@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rongyu Zang

Organizational Affiliation

Fudan University

Official's Role

Study Chair

Facility Information:

Facility Name

Zhongshan Hospital, Fudan University

City

Shanghai

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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