Skip to content

Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer

Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer: a Multicenter Real-world Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06385912
Enrollment
1090
Registered
2024-04-26
Start date
2006-07-01
Completion date
2021-02-10
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymph Node Excision, Neoadjuvant Therapy, Ovarian Cancer, Postoperative Complications

Keywords

Advanced epithelial ovarian cancer, Lymphadenectomy, Neoadjuvant chemotherapy, Interval debulking surgery, Prognosis, Postoperative complication

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.

Interventions

PROCEDURElymphadenectomy

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

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 yearsOverall 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.
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 yearsThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026