Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer

Completed

• Conditions: Ovarian Cancer; Postoperative Complications; Neoadjuvant Therapy; Lymph Node Excision
• Interventions: Procedure: lymphadenectomy

• Registration Number: NCT06385912
• Lead Sponsor: Tongji Hospital

Brief Summary

The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The main question it aims to answer is:

Does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy?

The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question.

Detailed Description

The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The study included patients with histologically confirmed advanced epithelial ovarian cancer who received IDS at seven tertiary hospitals in China from 2006 to 2021. The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups. Propensity score matching (PSM) and overlapping weight (OW) analyses were performed to minimize selection bias.

Study Timeline

• Study Start: 2006-07-01
• Primary Completion: 2021-02-10
• Study Completion: 2021-02-10
• Status Verified: 2024-04
• Study First Submitted: 2024-04-20
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1090

Inclusion Criteria

1. Consecutive patients with advanced epithelial ovarian cancer (stage IIB-IV, according to the International Federation of Gynecology and Obstetrics (FIGO) 2014);
2. Patients who underwent NACT followed by IDS.

Exclusion Criteria

1. Patients with early-stage ovarian cancer (FIGO stage I-IIA);
2. Patients only receiving primary debulking surgery (PDS) as initial treatment without NACT;
3. Histological subtypes other than advanced epithelial ovarian cancer;
4. Patients with unclear sites of lymphadenectomy and non-compliant systematic lymphadenectomy that not include pelvic and/or para-aortic lymph nodes.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lymphadenectomy group	lymphadenectomy	Patients received lymphadenectomy during IDS

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	From the initial diagnosis to the occurrence of recurrence, progression, death, or the latest follow-up, whichever came first, until February 10, 2021, an average of 3 years	The progression-free survival (PFS) was defined as the duration from the initial diagnosis to the occurrence of recurrence, progression, death, or the latest follow-up, whichever came first.
Overall survival (OS)	From the initial diagnosis to the occurrence of recurrence, progression, death, or the latest follow-up, whichever came first, until February 10, 2021, an average of 5 years	Overall survival (OS) was described as the duration from the date of diagnosis to the date of death from any cause or the last follow-up date.

Trial Locations

Locations (1)

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China