Lymphadenectomy in Early Ovarian Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2028
  • participants needed
    656
  • sponsor
    Sun Yat-sen University
Updated on 30 January 2021

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.

Description

OBJECTIVES: Compare the efficacy and safety in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA -IIA epithelial ovarian cancer, undergo completion staging surgery including systematic pelvic and para-aortic lymphadenectomy versus comprehensive staging surgery without lymphadenectomy.

OUTLINE: This is a randomized phase III multicenter study. Patients will receive comprehensive staging surgery without Lymphadenectomy or completion staging surgery including systematic pelvic and para-aortic lymphadenectomy, and the adjuvant chemotherapy will accord to National Comprehensive Cancer Network (NCCN) guidelines. Patients are followed up every 3 months within the first 2 years, and then every 6 months.

PROJECTED ACCRUAL: A total of 656 patients will be recruited for this study within 5 years.

Details
Condition Ovarian disorder, Lymphadenectomy, Ovarian Cancer, Ovarian Function, Recurrent Ovarian Cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, lymph node dissection, ovarian tumors
Treatment Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy, Comprehensive staging surgery with no Lymphadenectomy
Clinical Study IdentifierNCT04710797
SponsorSun Yat-sen University
Last Modified on30 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 chemotherapyHigh-grade serous carcinoma; Grade 3 endometrioid carcinoma; Clear cell carcinoma; Grade 2 endometrioid carcinoma with capsule ruptured or pelvic tissues extension Low-grade serous carcinomaGrade 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 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 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
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