Lymphadenectomy in Early Ovarian Cancer

NCT ID: NCT04710797

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 656 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2028-12-31

Brief Summary

To assess the impact of comprehensive staging surgery with no lymphadenectomy on survival and quality of life in patients with early-stage ovarian cancer.

Detailed Description

OBJECTIVES: Compare the efficacy and safety in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA -IIA epithelial ovarian cancer, undergo completion staging surgery including systematic pelvic and para-aortic lymphadenectomy versus comprehensive staging surgery without lymphadenectomy.

OUTLINE: This is a randomized phase III multicenter study. Patients will receive comprehensive staging surgery without Lymphadenectomy or completion staging surgery including systematic pelvic and para-aortic lymphadenectomy, and the adjuvant chemotherapy will accord to National Comprehensive Cancer Network (NCCN) guidelines. Patients are followed up every 3 months within the first 2 years, and then every 6 months.

PROJECTED ACCRUAL: A total of 656 patients will be recruited for this study within 5 years.

Conditions

Ovarian Cancer; Lymphadenectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No Lymphadenectomy

Comprehensive staging surgery with no Lymphadenectomy

Group Type: EXPERIMENTAL

Comprehensive staging surgery with no Lymphadenectomy

Intervention Type: PROCEDURE

• open or minimally invasive surgical approach
• cytologic examinations
• All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied
• BSO and hysterectomy
• For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered
• Omentectomy
• In open approach surgery, exploring the pelvic and Para-aortic lymph node with hand. In minimally invasive surgery, the peritoneal above the pelvic and Para-aortic lymph node area should be open and visualized.Biopsy and frozen section of the suspicious lymph nodes

Lymphadenectomy

Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

Group Type: ACTIVE_COMPARATOR

Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

Intervention Type: PROCEDURE

• open or minimally invasive surgical approach
• cytologic examinations
• All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied
• BSO and hysterectomy
• For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered
• Omentectomy
• Para-aortic lymph node dissection should be performed by stripping the nodal tissue from the vena cava and the aorta bilaterally to at least the level of the inferior mesenteric artery and preferably to the level of the renal vessels
• The preferred method of dissecting pelvic lymph nodes is bilateral removal of lymph nodes overlying and anterolateral to the common iliac vessel, overlying and medial to the external iliac vessel, overlying and medial to the hypogastric vessels, and from the obturator fossa at a minimum anterior to the obturator nerve

Interventions

Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

• open or minimally invasive surgical approach
• cytologic examinations
• All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied
• BSO and hysterectomy
• For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered
• Omentectomy
• Para-aortic lymph node dissection should be performed by stripping the nodal tissue from the vena cava and the aorta bilaterally to at least the level of the inferior mesenteric artery and preferably to the level of the renal vessels
• The preferred method of dissecting pelvic lymph nodes is bilateral removal of lymph nodes overlying and anterolateral to the common iliac vessel, overlying and medial to the external iliac vessel, overlying and medial to the hypogastric vessels, and from the obturator fossa at a minimum anterior to the obturator nerve

Intervention Type: PROCEDURE

Comprehensive staging surgery with no Lymphadenectomy

• open or minimally invasive surgical approach
• cytologic examinations
• All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied
• BSO and hysterectomy
• For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered
• Omentectomy
• In open approach surgery, exploring the pelvic and Para-aortic lymph node with hand. In minimally invasive surgery, the peritoneal above the pelvic and Para-aortic lymph node area should be open and visualized.Biopsy and frozen section of the suspicious lymph nodes

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Women aged 18 years to 70 years.

2. Primary diagnosis of epithelial ovarian cancer FIGO stage IA-IIA ( recevive no prior treatment or receive incomplete initial surgery)，with indications of adjuvant chemotherapy：①High-grade serous carcinoma; ②Grade 3 endometrioid carcinoma; ③Clear cell carcinoma; ④Grade 2 endometrioid carcinoma with capsule ruptured or pelvic tissues extension ⑤Low-grade serous carcinoma、Grade 1 endometrioid carcinoma and Mucinous carcinoma of the ovary with pelvic tissues extension.

3. Patients who have given their signed and written informed consent.

4. Good performance status (ECOG 0/1).

Exclusion Criteria

1. Non epithelial ovarian malignancies and borderline tumors.

2. Suspicious lymph nodes at preoperative radiological evaluation.

3. Intraoperative clinically suspicious lymph nodes (bulky nodes).

4. Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.

5. Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.

6. Diseases of the lymph system (including lymph edema of unknown origin).

7. Prior retroperitoneal lymph node dissection (systematic or sampling).

8. Any other concurrent medical conditions contraindicating surgery.

9. Pregnancy.

10. Any reasons interfering with giving of informed consent , abiding by protocol, or regular follow-up.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jihong Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jihong Liu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jihong Liu, Ph.D.

Role: CONTACT

liujih@mail.sysu.edu.cn

86-20-87343102

Ting Deng, Ph.D.

Role: CONTACT

dengting@sysucc.org.cn

86-20-87343105

Facility Contacts

Jihong Liu, Ph.D.

Role: primary

liujih@mail.sysu.edu.cn

86-20-87343102

Ting Deng, Ph.D.

Role: backup

dengting@sysucc.org.cn

86-20-87343105

References

Deng T, Liu K, Chen L, Chen X, Li HW, Guo H, Zhang H, Xiang L, Feng X, Wang X, Ngan HY, Zhao J, Zou D, Liu Q, Liu J. A prospective randomized multicenter trial for lymphadenectomy in early-stage ovarian cancer: LOVE study. J Gynecol Oncol. 2023 May;34(3):e52. doi: 10.3802/jgo.2023.34.e52. Epub 2023 Apr 10.

Reference Type: DERIVED

PMID: 37116952 (View on PubMed)

Other Identifiers

2020-FXY-405

Identifier Type: -

Identifier Source: org_study_id