Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer
ovarian cancer
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2020
CompletedFirst Posted
Study publicly available on registry
February 6, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFebruary 6, 2020
February 1, 2020
1.8 years
February 4, 2020
February 4, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patient where complete resection of the tumor can be achieved
complete resection of the tumor
3 month postoperative
Study Arms (2)
Group 1
ACTIVE COMPARATOR1ry surgery
Group 2
ACTIVE COMPARATORNeoadjuvant Chemotherapy followed by surgery
Interventions
chemotherapy then surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ali hussien Ali sayed
Asyut, 71111, Egypt
Related Publications (1)
Abutaleb H, Hussien A, Khalaf M, Badary DM, Ismail AM, Hassanein S, AlGizawy S, Moustafa SAM, Farghaly RMM, Abdel-Kawi AF. Primary Cytoreductive Surgery Versus Neoadjuvant Chemotherapy Followed by Surgery in Patients with Advanced Primary Epithelial Ovarian Cancer in Low Resources Setting: A Randomized Clinical Trial. J Obstet Gynaecol India. 2025 Jun;75(3):199-205. doi: 10.1007/s13224-024-02061-w. Epub 2024 Nov 6.
PMID: 40584804DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist
Study Record Dates
First Submitted
February 4, 2020
First Posted
February 6, 2020
Study Start
March 1, 2020
Primary Completion
December 30, 2021
Study Completion
April 1, 2022
Last Updated
February 6, 2020
Record last verified: 2020-02