Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy (SDLNOC)

June 23, 2023 updated by: Hee Seung Kim, Seoul National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

121

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • 시/도/주
      • Seoul, 시/도/주, Korea, Republic of, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients underwent treatment at University Hospital.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Borderline or benign ovarian disease
  • Patient didn't undergo debulking surgery
  • Non-epithelial ovarian cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From the date of treatment start date until death due to any cause, assessed up to 120 months
the time interval from the treatment start date to death or end of study date
From the date of treatment start date until death due to any cause, assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee Seung Kim, Pf, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 13, 2021

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDLNOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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