Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy

NCT05005650 | Completed

• 1 other identifier: SDLNOC
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer Stage IV; Lymph Node Metastases

Keywords

internal mammary lymph node; supraclavicular lymph node; cardiophrenic lymph node

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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 Outcomes (1)

• Overall survival

  From the date of treatment start date until death due to any cause, assessed up to 120 months

Interventions

debulking surgery PROCEDURE

debulking surgery as primary debulking surgery or interval debulking surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients underwent treatment at University Hospital.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 시/도/주, 03080, South Korea

Location

Related Publications (5)

• 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.

  PMID: 27016223 BACKGROUND

• Ataseven 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.

  PMID: 26691222 BACKGROUND

• Lim 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.

  PMID: 19408045 BACKGROUND

• Yoo 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.

  PMID: 23290988 BACKGROUND

• Park 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.

  PMID: 37637060 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Lymphatic Metastasis

Interventions

Cytoreduction Surgical Procedures

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Hee Seung Kim, Pf

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 13, 2021
• Study Start: June 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)