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Lymphadenectomy in Early Ovarian Cancer (LOVE)

Primary Purpose

Ovarian Cancer, Lymphadenectomy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy
Comprehensive staging surgery with no Lymphadenectomy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Gynecologic Oncology, Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

No Lymphadenectomy

Lymphadenectomy

Arm Description

Comprehensive staging surgery with no Lymphadenectomy

Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

Outcomes

Primary Outcome Measures

PFS(Progression-free survival)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

Secondary Outcome Measures

OS(Overall Survival)
From date of randomization until the date of death from any cause or date of last follow up, whichever came first
Recurrence rate of lymph node
The recurrence rate in the retroperitoneal lymph nodes after primary surgery
QoL(Quality of life)
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
Postoperative complications
The difference of the rate of Postoperative complications between two groups

Full Information

First Posted
January 11, 2021
Last Updated
January 13, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04710797
Brief Title
Lymphadenectomy in Early Ovarian Cancer
Acronym
LOVE
Official Title
A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2021 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comprehensive staging surgery with or without lymphadenectomy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
656 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No Lymphadenectomy
Arm Type
Experimental
Arm Description
Comprehensive staging surgery with no Lymphadenectomy
Arm Title
Lymphadenectomy
Arm Type
Active Comparator
Arm Description
Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy
Intervention Description
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
Intervention Name(s)
Comprehensive staging surgery with no Lymphadenectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
PFS(Progression-free survival)
Description
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
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
Secondary Outcome Measure Information:
Title
OS(Overall Survival)
Description
From date of randomization until the date of death from any cause or date of last follow up, whichever came first
Time Frame
From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons
Title
Recurrence rate of lymph node
Description
The recurrence rate in the retroperitoneal lymph nodes after primary surgery
Time Frame
3 years
Title
QoL(Quality of life)
Description
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
Time Frame
Baseline, 6 months and 1 year after surgery
Title
Postoperative complications
Description
The difference of the rate of Postoperative complications between two groups
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women aged 18 years to 70 years. 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. Patients who have given their signed and written informed consent. Good performance status (ECOG 0/1). Exclusion Criteria: Non epithelial ovarian malignancies and borderline tumors. Suspicious lymph nodes at preoperative radiological evaluation. Intraoperative clinically suspicious lymph nodes (bulky nodes). 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. Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy. Diseases of the lymph system (including lymph edema of unknown origin). Prior retroperitoneal lymph node dissection (systematic or sampling). Any other concurrent medical conditions contraindicating surgery. Pregnancy. Any reasons interfering with giving of informed consent , abiding by protocol, or regular follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jihong Liu, Ph.D.
Phone
86-20-87343102
Email
liujih@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Deng, Ph.D.
Phone
86-20-87343105
Email
dengting@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, Ph.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jihong Liu, Ph.D.
Phone
86-20-87343102
Email
liujih@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Ting Deng, Ph.D.
Phone
86-20-87343105
Email
dengting@sysucc.org.cn

12. IPD Sharing Statement

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Lymphadenectomy in Early Ovarian Cancer

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