Assessing surgery options for early ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.