NCT06385912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,090

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
14.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

14.6 years

First QC Date

April 20, 2024

Last Update Submit

April 23, 2024

Conditions

Ovarian CancerPostoperative ComplicationsNeoadjuvant TherapyLymph Node Excision

Keywords

Advanced epithelial ovarian cancerLymphadenectomyNeoadjuvant chemotherapyInterval debulking surgeryPrognosisPostoperative complication

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

lymphadenectomy group

Patients received lymphadenectomy during IDS

Procedure: lymphadenectomy

no lymphadenectomy group

Patients did not receive lymphadenectomy during IDS

Interventions

lymphadenectomyPROCEDURE

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

lymphadenectomy group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Ovarian NeoplasmsPostoperative Complications

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Qinglei Gao, MD, PhD

    Tongji Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2024

First Posted

April 26, 2024

Study Start

July 1, 2006

Primary Completion

February 10, 2021

Study Completion

February 10, 2021

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations

CN(1)