Lymphadenectomy in Early Ovarian Cancer

Not Applicable

Recruiting

• Conditions: Ovarian Cancer; Lymphadenectomy
• Interventions: Procedure: Comprehensive staging surgery with no Lymphadenectomy; Procedure: Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

• Registration Number: NCT04710797
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15
• Study Start: 2021-01-31
• Primary Completion: 2025-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 656

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Lymphadenectomy	Comprehensive staging surgery with no Lymphadenectomy	Comprehensive staging surgery with no Lymphadenectomy
Lymphadenectomy	Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy	Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

Primary Outcome Measures

Name	Time	Method
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, 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

Name	Time	Method
QoL(Quality of life)	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
Recurrence rate of lymph node	3 years	The recurrence rate in the retroperitoneal lymph nodes after primary surgery
OS(Overall Survival)	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
Postoperative complications	3 years	The difference of the rate of Postoperative complications between two groups

Trial Locations

Locations (1)

Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China