Assessing surgery options for early ovarian cancer
A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
This study is testing two different types of surgery for women with early ovarian cancer to see which one helps them live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 656 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04710797 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of two surgical approaches in women with early-stage epithelial ovarian cancer. Participants will be randomly assigned to either undergo comprehensive staging surgery without lymphadenectomy or complete staging surgery that includes systematic pelvic and para-aortic lymphadenectomy. The goal is to compare the efficacy and safety of these approaches in terms of survival and quality of life. Patients will receive follow-up care every three months for the first two years and then every six months thereafter.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 70 with a primary diagnosis of FIGO stage IA-IIA epithelial ovarian cancer who have not received prior treatment.
Not a fit: Patients with non-epithelial ovarian malignancies, suspicious lymph nodes, or secondary invasive neoplasms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the best surgical approach to improve survival and quality of life for patients with early-stage ovarian cancer.
How similar studies have performed: While there have been studies on lymphadenectomy in various cancers, this specific approach in early ovarian cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Jihong Liu, Ph.D. — Sun Yat-sen University
- Study coordinator: Jihong Liu, Ph.D.
- Email: liujih@mail.sysu.edu.cn
- Phone: 86-20-87343102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.