Lymphadenectomy in Early Ovarian Cancer

Last updated: January 13, 2021
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Cancer

Ovarian Cancer

Pelvic Cancer

Treatment

N/A

Clinical Study ID

NCT04710797
2020-FXY-405
  • Ages 18-70
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Women aged 18 years to 70 years.
  2. Primary diagnosis of epithelial ovarian cancer FIGO stage IA-IIA ( recevive no priortreatment or receive incomplete initial surgery),with indications of adjuvantchemotherapy:①High-grade serous carcinoma; ②Grade 3 endometrioid carcinoma; ③Clearcell carcinoma; ④Grade 2 endometrioid carcinoma with capsule ruptured or pelvictissues extension ⑤Low-grade serous carcinoma、Grade 1 endometrioid carcinoma andMucinous carcinoma of the ovary with pelvic tissues extension.
  3. Patients who have given their signed and written informed consent.
  4. Good performance status (ECOG 0/1).

Exclusion

Exclusion Criteria:

  1. Non epithelial ovarian malignancies and borderline tumors.
  2. Suspicious lymph nodes at preoperative radiological evaluation.
  3. Intraoperative clinically suspicious lymph nodes (bulky nodes).
  4. Secondary invasive neoplasms in the last 5 years (except synchronal endometrialcarcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or withany signs of relapse or activity.
  5. Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
  6. Diseases of the lymph system (including lymph edema of unknown origin).
  7. Prior retroperitoneal lymph node dissection (systematic or sampling).
  8. Any other concurrent medical conditions contraindicating surgery.
  9. Pregnancy.
  10. Any reasons interfering with giving of informed consent , abiding by protocol, orregular follow-up.

Study Design

Total Participants: 656
Study Start date:
January 31, 2021
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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