Lymphadenectomy in Early Ovarian Cancer (LOVE)

January 13, 2021 updated by: Jihong Liu, Sun Yat-sen University

A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

656

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No Lymphadenectomy
Comprehensive staging surgery with no Lymphadenectomy
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
Active Comparator: Lymphadenectomy
Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS(Progression-free survival)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS(Overall Survival)
Time Frame: From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons
From date of randomization until the date of death from any cause or date of last follow up, whichever came first
From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons
Recurrence rate of lymph node
Time Frame: 3 years
The recurrence rate in the retroperitoneal lymph nodes after primary surgery
3 years
QoL(Quality of life)
Time Frame: Baseline, 6 months and 1 year after surgery
Quality of life before surgery, and at 6 months and 1 year after surgery in both groups will be evaluated using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
Baseline, 6 months and 1 year after surgery
Postoperative complications
Time Frame: 3 years
The difference of the rate of Postoperative complications between two groups
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Jihong Liu, Ph.D., Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 31, 2021

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2028

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-FXY-405

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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