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Lymphadenectomy in Early Ovarian Cancer (LOVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04710797
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Jihong Liu, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Lymphadenectomy Procedure: Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy Procedure: Comprehensive staging surgery with no Lymphadenectomy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 656 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: comprehensive staging surgery with or without lymphadenectomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
Estimated Study Start Date : January 31, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Recurrence rate of lymph node [ Time Frame: 3 years ]
    The recurrence rate in the retroperitoneal lymph nodes after primary surgery

  3. 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

  4. Postoperative complications [ Time Frame: 3 years ]
    The difference of the rate of Postoperative complications between two groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04710797


Contacts
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Contact: Jihong Liu, Ph.D. 86-20-87343102 liujih@mail.sysu.edu.cn
Contact: Ting Deng, Ph.D. 86-20-87343105 dengting@sysucc.org.cn

Locations
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China, Guangdong
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jihong Liu, Ph.D.    86-20-87343102    liujih@mail.sysu.edu.cn   
Contact: Ting Deng, Ph.D.    86-20-87343105    dengting@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Jihong Liu, Ph.D. Sun Yat-sen University
More Information
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Responsible Party: Jihong Liu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04710797    
Other Study ID Numbers: 2020-FXY-405
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type