SDLNOC: Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05005650
Collaborator
(none)
121
1
7
17.3

Study Details

Study Description

Brief Summary

To evaluate the survival impact of extensive lymphadenectomy as part of debulking surgery in stage IVB ovarian cancer with supradiaphragmatic lymph node metastasis.

Condition or Disease Intervention/Treatment Phase
  • Procedure: debulking surgery

Study Design

Study Type:
Observational
Anticipated Enrollment :
121 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy on Stage IVB Ovarian Cancer With Supradiaphragmatic Lymph Node Metastasis
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival [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

Secondary Outcome Measures

  1. Overall survival [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul 시/도/주 Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hee Seung Kim, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05005650
Other Study ID Numbers:
  • SDLNOC
First Posted:
Aug 13, 2021
Last Update Posted:
Aug 13, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hee Seung Kim, Associate Professor, Seoul National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2021