Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer

NCT ID: NCT06385912

Last Updated: 2024-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1090 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-01

Study Completion Date

2021-02-10

Brief Summary

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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

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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.

Conditions

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Ovarian Cancer Postoperative Complications Neoadjuvant Therapy Lymph Node Excision

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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lymphadenectomy group

Patients received lymphadenectomy during IDS

lymphadenectomy

Intervention Type PROCEDURE

Systematic pelvic and para-aortic lymphadenectomy during IDS in lymphadenectomy group

no lymphadenectomy group

Patients did not receive lymphadenectomy during IDS

No interventions assigned to this group

Interventions

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lymphadenectomy

Systematic pelvic and para-aortic lymphadenectomy during IDS in lymphadenectomy group

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qinglei Gao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qinglei Gao, MD, PhD

Role: STUDY_CHAIR

Tongji Hospital

Locations

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Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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2024-TJ-SLIDS

Identifier Type: -

Identifier Source: org_study_id

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