Last updated: January 13, 2021
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Vaginal Cancer
Ovarian Cancer
Pelvic Cancer
Treatment
N/AClinical Study ID
NCT04710797
2020-FXY-405
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women aged 18 years to 70 years.
- Primary diagnosis of epithelial ovarian cancer FIGO stage IA-IIA ( recevive no priortreatment or receive incomplete initial surgery),with indications of adjuvantchemotherapy:①High-grade serous carcinoma; ②Grade 3 endometrioid carcinoma; ③Clearcell carcinoma; ④Grade 2 endometrioid carcinoma with capsule ruptured or pelvictissues extension ⑤Low-grade serous carcinoma、Grade 1 endometrioid carcinoma andMucinous 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
Exclusion Criteria:
- 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 endometrialcarcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or withany 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, orregular follow-up.
Study Design
Total Participants: 656
Study Start date:
January 31, 2021
Estimated Completion Date:
December 31, 2028
Study Description
Connect with a study center
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.