Lymphadenectomy in Early Ovarian Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorSun Yat-sen University
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy
- Comprehensive staging surgery with no Lymphadenectomy
Treatment groups
656 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov