Clinical trial NCT04710797: Lymphadenectomy in Early Ovarian Cancer
Official title: A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lymphadenectomy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 656
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comprehensive staging surgery with or without lymphadenectomy
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: PFS(Progression-free survival)
timeFrame: 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 outcomes:
measure: OS(Overall Survival)
timeFrame: From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons
measure: Recurrence rate of lymph node
timeFrame: 3 years
measure: QoL(Quality of life)
timeFrame: Baseline, 6 months and 1 year after surgery
measure: Postoperative complications
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jihong Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: