Back to resultsPrimary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer (ovarian cancer)
Primary Purpose
Advanced Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
1ry cyto-reductive surgery
Neoadjuvant chemotherapy followed by surgery
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Cancer
Eligibility Criteria
Inclusion Criteria:
Female patients diagnosed with epithelial ovarian cancer (By histopathology)
Age ≥ 18 years old
Advanced defined as (stage 2D or more ) by surgical staging.
Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) ≤ 2
Chemotherapy naïve
Informed consent
Exclusion Criteria:
Patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis.
Patients with uncontrolled infection.
Patients with active bleeding or conditions associated with high risk of bleeding.
contraindications for surgery
contraindications To chemotherapy - bevacizumab
Sites / Locations
- Ali hussien Ali sayedRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
1ry surgery
Neoadjuvant Chemotherapy followed by surgery
Outcomes
Primary Outcome Measures
Percentage of patient where complete resection of the tumor can be achieved
complete resection of the tumor
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04257786
Brief Title
Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer
Acronym
ovarian cancer
Official Title
Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) Followed by Surgery in Patients With Advanced Primary Epithelial Ovarian Cancer: A Pilot Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Assessment of efficacy of primary cyto-reductive surgery in patients with advanced primary epithelial ovarian cancer in Comparison to patients receiving neo-adjuvant chemotherapy (NAC) followed by surgery in complete excision of the tumor reaching R0 without significant morbidity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
1ry surgery
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Neoadjuvant Chemotherapy followed by surgery
Intervention Type
Procedure
Intervention Name(s)
1ry cyto-reductive surgery
Other Intervention Name(s)
1ry surgery
Intervention Description
1ry surgery then chemotherapy
Intervention Type
Combination Product
Intervention Name(s)
Neoadjuvant chemotherapy followed by surgery
Other Intervention Name(s)
Neoadjuvant chemotherapy
Intervention Description
chemotherapy then surgery
Primary Outcome Measure Information:
Title
Percentage of patient where complete resection of the tumor can be achieved
Description
complete resection of the tumor
Time Frame
3 month postoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients diagnosed with epithelial ovarian cancer (By histopathology)
Age ≥ 18 years old
Advanced defined as (stage 2D or more ) by surgical staging.
Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) ≤ 2
Chemotherapy naïve
Informed consent
Exclusion Criteria:
Patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis.
Patients with uncontrolled infection.
Patients with active bleeding or conditions associated with high risk of bleeding.
contraindications for surgery
contraindications To chemotherapy - bevacizumab
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali H Ali Sayed, M.Sc
Phone
02 01061830890
Email
lolf372@gmail.com
Facility Information:
Facility Name
Ali hussien Ali sayed
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer
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