NCT04710797 Lymphadenectomy in Early Ovarian Cancer
| NCT ID | NCT04710797 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 656 participants |
| Start Date | 2021-01-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 656 participants in total. It began in 2021-01-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jihong Liu, Ph.D.
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT04710797 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04710797 currently recruiting?
Yes, NCT04710797 is actively recruiting participants. Contact the research team at liujih@mail.sysu.edu.cn for enrollment information.
Where is the NCT04710797 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04710797 clinical trial?
NCT04710797 is sponsored by Sun Yat-sen University. The principal investigator is Jihong Liu, Ph.D. at Sun Yat-sen University. The trial plans to enroll 656 participants.
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