Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy

Lymph Node Metastases Clinical Trial

— SDLNOC  

Official title:

Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy on Stage IVB Ovarian Cancer With Supradiaphragmatic Lymph Node Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005650
• Other study ID #: SDLNOC
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Lymph Node Metastases
• Lymphatic Metastasis
• Neoplasm Metastasis
• Ovarian Cancer Stage IV
• Ovarian Neoplasms

Intervention

Procedure:
• debulking surgery
debulking surgery as primary debulking surgery or interval debulking surgery

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	?/?/?

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	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