Back to resultsEvaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cardiophrenic lymph nodes resection
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
Inclusion criteria
- Ovarian cancer patient (FIGO stage III-IV)
- Preoperative CT showing CPLN with short axis diameter > 5mm.
- Anathestically fit patient (ASA score I or II).
- Accepted pulmonary function test.
- Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled
- Written informed consent.
- Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1 cm )
Exclusion Criteria:
- Anathestically unfit patient
- Unresectable disease
- Patient refusal
- No detected CPLN by preoperative radiology
Sites / Locations
- Oncology center, Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cardiophrenic nodes excision in ovarian cancer
Arm Description
We are going to evaluate the comorbidites and impact of cardiophrenic lymph nodes excision in cases of advanced ovarian cancer with positive cardiophrenic lymph nodes
Outcomes
Primary Outcome Measures
number of CPN retrieved/pathological nodes
correlation of radiological active lymph nodes with pathological findings
Secondary Outcome Measures
Progression free survival
2 years progression without disease recurrence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03235648
Brief Title
Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer
Official Title
Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of surgical excision of cardiophrenic lymph nodes in patients with advanced ovarian cancer
Detailed Description
The role of cardiophrenic lymph node assessment and excision in advanced ovarian cancer is still debatable , correlation of radiological finding with pathological findings after reaction of radiological positive lymph nodes and its impact in diseases free survival and over all survival
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cardiophrenic nodes excision in ovarian cancer
Arm Type
Experimental
Arm Description
We are going to evaluate the comorbidites and impact of cardiophrenic lymph nodes excision in cases of advanced ovarian cancer with positive cardiophrenic lymph nodes
Intervention Type
Procedure
Intervention Name(s)
cardiophrenic lymph nodes resection
Intervention Description
surgical resection
Primary Outcome Measure Information:
Title
number of CPN retrieved/pathological nodes
Description
correlation of radiological active lymph nodes with pathological findings
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Progression free survival
Description
2 years progression without disease recurrence
Time Frame
up to 2 years following the end of study
Other Pre-specified Outcome Measures:
Title
Overall survival
Description
2 years survivals of the patients
Time Frame
up to 2 years following the end of study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Ovarian cancer patient (FIGO stage III-IV)
Preoperative CT showing CPLN with short axis diameter > 5mm.
Anathestically fit patient (ASA score I or II).
Accepted pulmonary function test.
Patient who received neoadjuvant chemotherapy or recurrent cases may be enrolled
Written informed consent.
Achievement of optimal cytoreduction intra-abdominal( No residual disease more than 1 cm )
Exclusion Criteria:
Anathestically unfit patient
Unresectable disease
Patient refusal
No detected CPLN by preoperative radiology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Basel R. Abdelfattah, MD, MRCS
Phone
01001974340
Ext
+2
Email
dr.basel@hotmail.com
Facility Information:
Facility Name
Oncology center, Mansoura University
City
Cairo
State/Province
Dakhlia
ZIP/Postal Code
35116
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basel R. Abdelfattah, MD,MRCS
Phone
01001974340
Ext
+2
Email
dr.basel@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Surgical Excision of Cardiophrenic Lymph Nodes in Patients With Advanced Ovarian Cancer
We'll reach out to this number within 24 hrs