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

February 4, 2020 updated by: Ali hussien ali sayed, Assiut University

Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) Followed by Surgery in Patients With Advanced Primary Epithelial Ovarian Cancer: A Pilot Randomized Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Recruiting
        • Ali hussien Ali sayed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
1ry surgery
Procedure: 1ry cyto-reductive surgery
1ry surgery then chemotherapy
Other Names:
  • 1ry surgery
Active Comparator: Group 2
Neoadjuvant Chemotherapy followed by surgery
Combination product: Neoadjuvant chemotherapy followed by surgery
chemotherapy then surgery
Other Names:
  • Neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patient where complete resection of the tumor can be achieved
Time Frame: 3 month postoperative
complete resection of the tumor
3 month postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • epithelial ovarian cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe