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Evaluation 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
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
July 2, 2017
Last Updated
July 30, 2017
Sponsor
Mansoura University
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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

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