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NCT Number: NCT04710797

Lymphadenectomy in Early 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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Lymphadenectomy Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

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

Comprehensive staging surgery with no Lymphadenectomy

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

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jihong Liu, Ph.D.

CONTACT

[email protected]

86-20-87343102

Ting Deng, Ph.D.

CONTACT

[email protected]

86-20-87343105

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: LOVE

Important dates

Study start
2021
Primary completion
2025
Study completion
2028
First posted
Jan 15, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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