Clinical trial NCT05005650: Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy
Official title: Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy on Stage IVB Ovarian Cancer With Supradiaphragmatic Lymph Node Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer Stage IV
Lymph Node Metastases
Keywords: internal mammary lymph node
supraclavicular lymph node
cardiophrenic lymph node
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent treatment at University Hospital.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: 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:
measure: Overall survival
timeFrame: From the date of treatment start date until death due to any cause, assessed up to 120 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: 시/도/주
Study officials:
affiliation: Seoul National University Hospital
name: Hee Seung Kim, Pf
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.