Lymphadenectomy in Early Ovarian Cancer (LOVE)

Sun Yat-sen University

Status: Enrolling

Conditions: Lymphadenectomy; Ovarian Cancer

Treatments: Procedure: Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy; Procedure: Comprehensive staging surgery with no Lymphadenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04710797

2020-FXY-405

Details and patient eligibility

About

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

Full 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.

Enrollment: 656 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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656 participants in 2 patient groups

No Lymphadenectomy

Experimental group

Description:

Comprehensive staging surgery with no Lymphadenectomy

Treatment:

Procedure: Comprehensive staging surgery with no Lymphadenectomy

Lymphadenectomy

Active Comparator group

Description:

Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

Treatment:

Procedure: Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy