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NCT04257786 Clinical Trial

Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer

Advanced Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04257786
Other study ID # epithelial ovarian cancer
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date April 1, 2022

Study information
Verified date February 2020
Source Assiut University
Contact Ali H Ali Sayed, M.Sc
Phone 02 01061830890
Email lolf372@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date April 1, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 1ry cyto-reductive surgery
1ry surgery then chemotherapy
Combination Product:
• Neoadjuvant chemotherapy followed by surgery
chemotherapy then surgery

Locations
Country Name City State
Egypt Ali hussien Ali sayed Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patient where complete resection of the tumor can be achieved complete resection of the tumor 3 month postoperative
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