Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer (GO SOAR2)

August 30, 2022 updated by: Faiza Gaba, NHS Grampian

Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer: A GO SOAR Led Study (GO SOAR2)

To compare patient outcomes following interval and delayed cytoreductive surgeries and no surgery (neoadjuvant chemotherapy alone) and international variations in access to cytoreductive surgeries in women with advanced stage ovarian cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Standard of care in patients with advanced ovarian cancer is primary cytoreductive surgery followed by chemotherapy. Neoadjuvant chemotherapy and interval cytoreductive surgery is an alternative in selected patients. Most data exist with interval cytoreductive surgery following 3-4 cycles of chemotherapy, however, some patients experience a delay. So far, the impact of delayed cytoreductive surgery (following >5 cycles of chemotherapy) on patient outcomes is poorly defined. There is also a paucity of data in women who undergo no surgery (>5 cycles of chemotherapy alone) and factors influencing international discrepancies in access to cytoreductive surgery.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

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

Study Contact

Study Locations

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women with stage III-IV ovarian cancer

Description

Inclusion Criteria:

Women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) or delayed (>5 cycles of chemotherapy) cytoreductive surgeries or no cytoreductive surgery (>5 cycles of chemotherapy alone.

Exclusion Criteria:

Women undergoing recurrent cytoreductive surgery.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
interval cytoreductive surgery
women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) cytoreductive surgery
Procedure: interval cytoreductive surgery
cytoreductive surgery after 3-4 cycles of chemotherapy
delayed cytoreductive surgery
women with stage III-IV ovarian cancer, undergoing delayed (>5 cycles of chemotherapy) cytoreductive surgery
Procedure: delayed cytoreductive surgery
surgery after >5 cycles of chemotherapy
no surgery
women with stage III-IV ovarian cancer, undergoing >5 cycles of chemotherapy alone (no cytoreductive surgery)
Other: no surgery
no cytoreductive surgery (>5 cycles of chemotherapy alone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 15 years
defined from date of diagnosis to date of death by any cause or loss to follow-up
15 years
progression free survival
Time Frame: 15 years
defined from date of diagnosis to date of first recurrence
15 years
facilitator/barriers to access to cytoreductive surgery
Time Frame: 15 years
topic guide interview questionnaire to be used to elicit factors aiding/preventing access to cytoreductive surgery internationally
15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative morbidity
Time Frame: within 30 days from date of surgery
as per Clavien-Dindo classification
within 30 days from date of surgery
Resectability rates
Time Frame: at time of surgery
R0 = no visible disease, R1 = <10mm visible residual disease, R2 = >10mm visible residual disease
at time of surgery

Collaborators and Investigators

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

Sponsor

NHS Grampian

Collaborators

Barts & The London NHS Trust
Queen Mary University of London
University of Aberdeen

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)

August 26, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

August 31, 2022

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5719

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

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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