Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers

April 9, 2022 updated by: Ahmed Sohaib, Menoufia University

Clinical Outcomes of Secondary Cytoreductive Surgery in Platinum-resistant Ovarian Cancers With Isolated Recurrence

This novel study was specifically designed for platinum resistant recurrent ovarian cancers and aimed to compare cases who received secondary cytoreductive surgery for isolated recurrence and chemotherapy versus chemotherapy alone. This comparison will conduct the intraoperative events, postoperative morbidity and mortality, pathological outcomes and long-term oncological outcomes as regarding progression free survival and overall survival rates.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Baseline postoperative imaging with the use of abdominopelvic CT or MRI was to be completed during a 28-day window in which chemotherapy was initiated. Disease is also assessed after cycles 3 and 6 of trial treatment (and after cycle 8, if administered), every 3 months for 2 years, and then every 6 months thereafter. Physical examinations will be performed, and serum CA-125 levels measured at the beginning of each cycle of chemotherapy. Treatment-free interval (6 to 12 months or >12 months after the last chemotherapy infusion) will be reported.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

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
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt, 32511
        • Menoufia University, Faculty of medicine

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • platinum-resistant, recurrent epithelial ovarian cancer
  • amenable to complete gross resection, isolated recurrence
  • adequate renal, hepatic, and bone marrow function,
  • performance-status ECOG score of 0 to 2.

Exclusion Criteria:

  • not medically fit for surgery
  • diffuse carcinomatosis, ascites, or extra-abdominal disease

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: surgery + chemotherapy
surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice
Procedure: secondary cytoreductive surgery
resection of isolated recurrent ovarian carcinoma in platinum resistant disease
Other Names:
  • re-resection
Drug: Chemotherapy
second line chemotherapy according to investigator's choice
ACTIVE_COMPARATOR: chemotherapy alone
second line chemotherapy according to investigator's choice
Drug: Chemotherapy
second line chemotherapy according to investigator's choice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival (PFS)
Time Frame: 6 months from enrollment
the time interval between the first relapse and the second relapse
6 months from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 18 months from enrollment
the time interval between the date of diagnosis till the date of death
18 months from enrollment
Adverse events (AE)
Time Frame: 6 months from enrollment
described according to the CTCAE
6 months from enrollment

Collaborators and Investigators

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

Sponsor

Menoufia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

April 1, 2021

Primary Completion (ACTUAL)

April 9, 2022

Study Completion (ACTUAL)

April 9, 2022

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (ACTUAL)

March 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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