Clinical trial NCT06385912: Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer
Official title: Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer: a Multicenter Real-world Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Postoperative Complications
Neoadjuvant Therapy
Lymph Node Excision
Keywords: Advanced epithelial ovarian cancer
Lymphadenectomy
Neoadjuvant chemotherapy
Interval debulking surgery
Prognosis
Postoperative complication
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 1090
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 1090 patients diagnosed with FIGO stage IIB-IV epithelial ovarian cancer and who underwent IDS following NACT were selected for eligibility from July 2006 to February 2021 based on the NUWA Platform from 7 centers. Twenty-two patients who had unclear and non-compliant systematic lymphadenectomy were excluded and 1068 patients were enrolled in this study. Out of these patients, 528 (49.4%) had an IDS with lymphadenectomy, while 540 (50.6%) had an IDS without lymphadenectomy.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 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
measure: Overall survival (OS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Qinglei Gao, MD, PhD
role: STUDY_CHAIR
References: