Status:
RECRUITING
Lymphadenectomy in Early Ovarian Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Ovarian Cancer
Lymphadenectomy
Eligibility:
FEMALE
18-70 years
Phase:
NA
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 in...
Eligibility Criteria
Inclusion
- Women aged 18 years to 70 years.
- 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.
- Patients who have given their signed and written informed consent.
- Good performance status (ECOG 0/1).
Exclusion
- Non epithelial ovarian malignancies and borderline tumors.
- Suspicious lymph nodes at preoperative radiological evaluation.
- Intraoperative clinically suspicious lymph nodes (bulky nodes).
- 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.
- Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
- Diseases of the lymph system (including lymph edema of unknown origin).
- Prior retroperitoneal lymph node dissection (systematic or sampling).
- Any other concurrent medical conditions contraindicating surgery.
- Pregnancy.
- Any reasons interfering with giving of informed consent , abiding by protocol, or regular follow-up.
Key Trial Info
Start Date :
January 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
656 Patients enrolled
Trial Details
Trial ID
NCT04710797
Start Date
January 31 2021
End Date
December 31 2028
Last Update
January 15 2021
Active Locations (1)
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1
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060