Lymphadenectomy in Early Ovarian Cancer

NCT04710797 | Recruiting

• 1 other identifier: 2020-FXY-405
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Lymphadenectomy

Outcome Measures

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

  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 (4)

• OS(Overall Survival)

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

• Recurrence rate of lymph node

  3 years

• QoL(Quality of life)

  Baseline, 6 months and 1 year after surgery

• Postoperative complications

  3 years

Study Arms (2)

No Lymphadenectomy

EXPERIMENTAL

Comprehensive staging surgery with no Lymphadenectomy

Procedure: Comprehensive staging surgery with no Lymphadenectomy

Lymphadenectomy

ACTIVE COMPARATOR

Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

Procedure: Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy

Interventions

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

* 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

Lymphadenectomy

Comprehensive staging surgery with no Lymphadenectomy PROCEDURE

* 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

No Lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

• Deng T, Liu K, Chen L, Chen X, Li HW, Guo H, Zhang H, Xiang L, Feng X, Wang X, Ngan HY, Zhao J, Zou D, Liu Q, Liu J. A prospective randomized multicenter trial for lymphadenectomy in early-stage ovarian cancer: LOVE study. J Gynecol Oncol. 2023 May;34(3):e52. doi: 10.3802/jgo.2023.34.e52. Epub 2023 Apr 10.

  PMID: 37116952 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Jihong Liu, Ph.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihong Liu, Ph.D.

CONTACT

86-20-87343102; liujih@mail.sysu.edu.cn

Ting Deng, Ph.D.

CONTACT

86-20-87343105; dengting@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: comprehensive staging surgery with or without lymphadenectomy

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 15, 2021
• Study Start: January 31, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

CN (1)