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Lymphadenectomy in Early Ovarian Cancer

ConditionsOvarian CancerLymphadenectomy
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

    Procedure/Surgery

    * 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

  • Comprehensive staging surgery with no Lymphadenectomy

    Procedure/Surgery

    * 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

Treatment groups

656 Participants
are divided into 2 treatment groups
Group A: No LymphadenectomyExperimental treatment 1 intervention
Group B: LymphadenectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS(Progression-free survival)

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary outcomes

1

OS(Overall Survival)

From date of randomization until the date of death from any cause or date of last follow up, whichever came first

Time frame
From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons
2

Recurrence rate of lymph node

The recurrence rate in the retroperitoneal lymph nodes after primary surgery

Time frame
3 years
3

QoL(Quality of life)

Quality of life before surgery, and at 6 months and 1 year after surgery in both groups will be evaluated using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire

Time frame
Baseline, 6 months and 1 year after surgery
4

Postoperative complications

The difference of the rate of Postoperative complications between two groups

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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