Lymphadenectomy in Early Ovarian Cancer
A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer
Sun Yat-sen University
656 participants
Jan 31, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria10
- 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.
Interventions
* open or minimally invasive surgical approach * cytologic examinations * All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied * BSO and hysterectomy * For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered * Omentectomy * Para-aortic lymph node dissection should be performed by stripping the nodal tissue from the vena cava and the aorta bilaterally to at least the level of the inferior mesenteric artery and preferably to the level of the renal vessels * The preferred method of dissecting pelvic lymph nodes is bilateral removal of lymph nodes overlying and anterolateral to the common iliac vessel, overlying and medial to the external iliac vessel, overlying and medial to the hypogastric vessels, and from the obturator fossa at a minimum anterior to the obturator nerve
* open or minimally invasive surgical approach * cytologic examinations * All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied * BSO and hysterectomy * For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered * Omentectomy * In open approach surgery, exploring the pelvic and Para-aortic lymph node with hand. In minimally invasive surgery, the peritoneal above the pelvic and Para-aortic lymph node area should be open and visualized.Biopsy and frozen section of the suspicious lymph nodes
Locations(1)
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NCT04710797