Ovarian CancerNCT06385912
Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer
An observational study of Ovarian Cancer and Postoperative Complications, run by Tongji Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Postoperative Complications, Neoadjuvant Therapy
- What is being tested?
- lymphadenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,090 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2006to 10 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer: a Multicenter Real-world Study
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.
Read the 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.
- Being tested
- lymphadenectomy
- Keywords
- Advanced epithelial ovarian cancer, Lymphadenectomy, Neoadjuvant chemotherapy, Interval debulking surgery, Prognosis, Postoperative complication
- Medical subject headings
- Ovarian Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphadenectomyProcedure or surgery
Systematic pelvic and para-aortic lymphadenectomy during IDS in lymphadenectomy group
| Study group | Role | What they receive |
|---|---|---|
| lymphadenectomy group | Patients received lymphadenectomy during IDS Receives: Procedure: lymphadenectomy | |
| no lymphadenectomy group | Patients did not receive lymphadenectomy during IDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Jul 2006
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,090 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qinglei Gao, Tongji Hospital
- Investigators
- Qinglei Gao, MD, PhD, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385912
- Sponsor's protocol ID
- 2024-TJ-SLIDS
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer: a Multicenter Real-world Study
- ClinicalTrials.gov ID
- NCT06385912
- Acronym / sponsor ID
- 2024-TJ-SLIDS
- Keywords
- Advanced epithelial ovarian cancer, Lymphadenectomy, Neoadjuvant chemotherapy, Interval debulking surgery, Prognosis, Postoperative complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,090 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2006 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lymphadenectomy group | – | Procedure: lymphadenectomyPatients received lymphadenectomy during IDS |
| no lymphadenectomy group | – | –Patients did not receive lymphadenectomy during IDS |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lymphadenectomySystematic pelvic and para-aortic lymphadenectomy during IDS in lymphadenectomy group | Procedure or surgery | lymphadenectomy group |
Primary outcome
Progression free survival (PFS)
Time frame: 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
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.
Overall survival (OS)
Time frame: 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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Ovarian Cancer
Active, not recruiting
Ovarian Tissue Cryopreservation in Children
Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
RecruitingPhase 2
Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer
Ovarian Cancer
Recruiting
INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study
Breast Cancer, Corpus Uteri Cancer
Not yet recruitingPhase 2
Study of Suvemcitug Plus Chemotherapy in Advanced High-Grade Serous Ovarian Cancer
High-grade Serous Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qinglei Gao, MD, PhD study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Postoperative Complications, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.