Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06385912
• Other study ID #: 2024-TJ-SLIDS
• Status: Completed
• Start date: July 1, 2006
• Est. completion date: February 10, 2021

Study information

• Verified date: April 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1090
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Lymph Node Excision
• Neoadjuvant Therapy
• Ovarian Cancer
• Ovarian Neoplasms
• Postoperative Complications

Intervention

Procedure:
• lymphadenectomy
Systematic pelvic and para-aortic lymphadenectomy during IDS in lymphadenectomy group

Locations

Country	Name	City	State
China	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	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.	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
Primary	Overall survival (OS)	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.	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