Ovarian Cancer Stage IVSDLNOCNCT05005650
Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy
An observational study of Ovarian Cancer Stage IV and Lymph Node Metastases, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the survival impact of extensive lymphadenectomy as part of debulking surgery in stage IVB ovarian cancer with supradiaphragmatic lymph node metastasis. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Ovarian Cancer Stage IV, Lymph Node Metastases
- What is being tested?
- debulking surgery
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 31 Dec 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 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent treatment at University Hospital.
Who may be able to join
- Histologically diagnosed ovarian, fallopian tubal, primary peritoneal cancer
- Patients suspected of metastatic lymph nodes in the cardiophrenic, internal mammary, and/or supraclavicular lymph node by CT (size larger than 5mm)
- Patients clinically diagnosed FIGO stage IVB ovarian, fallopian tubal, primary peritoneal cancer
- Patients underwent debulking surgery (primary debulking surgery or interval debulking surgery) at Seoul National University Hospital from January 2010 to January 2020
- Patients age 18-90
Who cannot join
- Borderline or benign ovarian disease
- Patient didn't undergo debulking surgery
- Non-epithelial ovarian cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy on Stage IVB Ovarian Cancer With Supradiaphragmatic Lymph Node Metastasis
To evaluate the survival impact of extensive lymphadenectomy as part of debulking surgery in stage IVB ovarian cancer with supradiaphragmatic lymph node metastasis.
- Conditions
- Ovarian Cancer Stage IV, Lymph Node Metastases
- Being tested
- debulking surgery
- Keywords
- internal mammary lymph node, supraclavicular lymph node, cardiophrenic lymph node
- Medical subject headings
- Ovarian Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
debulking surgeryProcedure or surgery
debulking surgery as primary debulking surgery or interval debulking surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
the time interval from the treatment start date to disease recurrence or progression date
Measured: From date of treatment until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 120 months
Secondary outcomes (1)
Overall survival
the time interval from the treatment start date to death or end of study date
Measured: From the date of treatment start date until death due to any cause, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start1 Jun 2021
- Primary completion31 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ovarian Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Seung Kim, Seoul National University Hospital
- Investigators
- Hee Seung Kim, Pf, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005650
- Sponsor's protocol ID
- SDLNOC
- Acronym
- SDLNOC
- Status last verified
- Jun 2023
- First submitted
- 6 Aug 2021
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Randall LM, Pothuri B. The genetic prediction of risk for gynecologic cancers. Gynecol Oncol. 2016 Apr;141(1):10-6. doi: 10.1016/j.ygyno.2016.03.007.
PubMed 27016223Ataseven B, Grimm C, Harter P, Heitz F, Traut A, Prader S, du Bois A. Prognostic impact of debulking surgery and residual tumor in patients with epithelial ovarian cancer FIGO stage IV. Gynecol Oncol. 2016 Feb;140(2):215-20. doi: 10.1016/j.ygyno.2015.12.007. Epub 2015 Dec 12.
PubMed 26691222Lim MC, Lee HS, Jung DC, Choi JY, Seo SS, Park SY. Pathological diagnosis and cytoreduction of cardiophrenic lymph node and pleural metastasis in ovarian cancer patients using video-assisted thoracic surgery. Ann Surg Oncol. 2009 Jul;16(7):1990-6. doi: 10.1245/s10434-009-0486-5. Epub 2009 Apr 30.
PubMed 19408045Yoo HJ, Lim MC, Song YJ, Jung YS, Kim SH, Yoo CW, Park SY. Transabdominal cardiophrenic lymph node dissection (CPLND) via incised diaphragm replace conventional video-assisted thoracic surgery for cytoreductive surgery in advanced ovarian cancer. Gynecol Oncol. 2013 May;129(2):341-5. doi: 10.1016/j.ygyno.2012.12.023. Epub 2013 Jan 3.
PubMed 23290988Park SJ, Na KJ, Lee M, Park IK, Chung HH, Kang CH, Kim JW, Park NH, Kim YT, Song YS, Park S, Kim HS. Impact of supradiaphragmatic lymphadenectomy on the survival of patients in stage IVB ovarian cancer with thoracic lymph node metastasis. Front Oncol. 2023 Aug 10;13:1203127. doi: 10.3389/fonc.2023.1203127. eCollection 2023.
PubMed 37637060
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy on Stage IVB Ovarian Cancer With Supradiaphragmatic Lymph Node Metastasis
- ClinicalTrials.gov ID
- NCT05005650
- Acronym / sponsor ID
- SDLNOC / SDLNOC
- Conditions
- Ovarian Cancer Stage IV, Lymph Node Metastases
- Keywords
- internal mammary lymph node, supraclavicular lymph node, cardiophrenic lymph node
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Aug 2021 (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.
To evaluate the survival impact of extensive lymphadenectomy as part of debulking surgery in stage IVB ovarian cancer with supradiaphragmatic lymph node metastasis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent treatment at University Hospital.
Key inclusion criteria (5 listed)
- Histologically diagnosed ovarian, fallopian tubal, primary peritoneal cancer
- Patients suspected of metastatic lymph nodes in the cardiophrenic, internal mammary, and/or supraclavicular lymph node by CT (size larger than 5mm)
- Patients clinically diagnosed FIGO stage IVB ovarian, fallopian tubal, primary peritoneal cancer
- Patients underwent debulking surgery (primary debulking surgery or interval debulking surgery) at Seoul National University Hospital from January 2010 to January 2020
- Patients age 18-90
Key exclusion criteria (3 listed)
- Borderline or benign ovarian disease
- Patient didn't undergo debulking surgery
- Non-epithelial ovarian cancer
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 |
|---|---|---|
| debulking surgerydebulking surgery as primary debulking surgery or interval debulking surgery | Procedure or surgery | – |
Primary outcome
Progression-free survival
Time frame: From date of treatment until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 120 months
the time interval from the treatment start date to disease recurrence or progression date
1 secondary outcome
Overall survival
Time frame: From the date of treatment start date until death due to any cause, assessed up to 120 months
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 Jun 2023.
- Background: PubMed 27016223Randall LM, Pothuri B. The genetic prediction of risk for gynecologic cancers. Gynecol Oncol. 2016 Apr;141(1):10-6. doi: 10.1016/j.ygyno.2016.03.007.
- Background: PubMed 26691222Ataseven B, Grimm C, Harter P, Heitz F, Traut A, Prader S, du Bois A. Prognostic impact of debulking surgery and residual tumor in patients with epithelial ovarian cancer FIGO stage IV. Gynecol Oncol. 2016 Feb;140(2):215-20. doi: 10.1016/j.ygyno.2015.12.007. Epub 2015 Dec 12.
- Background: PubMed 19408045Lim MC, Lee HS, Jung DC, Choi JY, Seo SS, Park SY. Pathological diagnosis and cytoreduction of cardiophrenic lymph node and pleural metastasis in ovarian cancer patients using video-assisted thoracic surgery. Ann Surg Oncol. 2009 Jul;16(7):1990-6. doi: 10.1245/s10434-009-0486-5. Epub 2009 Apr 30.
- Background: PubMed 23290988Yoo HJ, Lim MC, Song YJ, Jung YS, Kim SH, Yoo CW, Park SY. Transabdominal cardiophrenic lymph node dissection (CPLND) via incised diaphragm replace conventional video-assisted thoracic surgery for cytoreductive surgery in advanced ovarian cancer. Gynecol Oncol. 2013 May;129(2):341-5. doi: 10.1016/j.ygyno.2012.12.023. Epub 2013 Jan 3.
- Derived from this study: PubMed 37637060Park SJ, Na KJ, Lee M, Park IK, Chung HH, Kang CH, Kim JW, Park NH, Kim YT, Song YS, Park S, Kim HS. Impact of supradiaphragmatic lymphadenectomy on the survival of patients in stage IVB ovarian cancer with thoracic lymph node metastasis. Front Oncol. 2023 Aug 10;13:1203127. doi: 10.3389/fonc.2023.1203127. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Hee Seung Kim, Pf principal investigator
Seoul National University 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 Stage IV and Lymph Node Metastases, run by Seoul National University Hospital at 1 site in South Korea.
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 5 inclusion and 3 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 Jun 2023. 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 South Korea. 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 (time frame: From date of treatment until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05005650, which also lists 5 linked publications.
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 Jun 2023.