NCT04710797Recruiting
Lymphadenectomy in Early Ovarian Cancer
A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 15 Jan 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To assess the impact of comprehensive staging surgery with no lymphadenectomy on survival and quality of life in patients with early-stage ovarian cancer.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 656 (estimated)
- First submitted
- 11 Jan 2021
- Start date
- 31 Jan 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Ovarian cancer
- NCT number
- NCT04710797
What you commit to
- Study type: Interventional
- Planned participants: 656
- From 31 Jan 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
- Prior retroperitoneal lymph node dissection (systematic or sampling).
- Any other concurrent medical conditions contraindicating surgery.
Other illness
- Non epithelial ovarian malignancies and borderline tumors.
- 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.
- Diseases of the lymph system (including lymph edema of unknown origin).
Other
- Suspicious lymph nodes at preoperative radiological evaluation.
- Intraoperative clinically suspicious lymph nodes (bulky nodes).
- Pregnancy.
- Any reasons interfering with giving of informed consent , abiding by protocol, or regular follow-up.
Who the study is looking for
- 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).
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.