NCT05523804

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 26, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

August 26, 2022

Last Update Submit

August 30, 2022

Conditions

Ovarian Cancer

Keywords

survivalmorbiditycytoreductiondisparities

Outcome Measures

Primary Outcomes (3)

  • overall survival

    defined from date of diagnosis to date of death by any cause or loss to follow-up

    15 years

  • progression free survival

    defined from date of diagnosis to date of first recurrence

    15 years

  • facilitator/barriers to access to cytoreductive surgery

    topic guide interview questionnaire to be used to elicit factors aiding/preventing access to cytoreductive surgery internationally

    15 years

Secondary Outcomes (2)

  • Post-operative morbidity

    within 30 days from date of surgery

  • Resectability rates

    at time of surgery

Study Arms (3)

interval cytoreductive surgery

women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) cytoreductive surgery

Procedure: interval cytoreductive surgery

delayed cytoreductive surgery

women with stage III-IV ovarian cancer, undergoing delayed (\>5 cycles of chemotherapy) cytoreductive surgery

Procedure: delayed cytoreductive surgery

no surgery

women with stage III-IV ovarian cancer, undergoing \>5 cycles of chemotherapy alone (no cytoreductive surgery)

Other: no surgery

Interventions

interval cytoreductive surgeryPROCEDURE

cytoreductive surgery after 3-4 cycles of chemotherapy

interval cytoreductive surgery
delayed cytoreductive surgeryPROCEDURE

surgery after \>5 cycles of chemotherapy

delayed cytoreductive surgery
no surgeryOTHER

no cytoreductive surgery (\>5 cycles of chemotherapy alone)

no surgery

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women with stage III-IV ovarian cancer

You may qualify if:

  • 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.

You may not qualify if:

  • Women undergoing recurrent cytoreductive surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal London Hospital

London, E1 1FR, United Kingdom

RECRUITING

Related Publications (1)

  • Gaba F, Ash K, Blyuss O, Bizzarri N, Kamfwa P, Ramirez PT, Kotsopoulos IC, Chandrasekaran D, Gomes N, Butler J, Nobbenhuis M, Ind T, Heath O, Barton D, Jeyarajah A, Brockbank E, Lawrence A, Dilley J, Manchanda R, Phadnis S, Soar GO. Patient outcomes following interval and delayed cytoreductive surgery in advanced ovarian cancer: protocol for a multicenter, international, cohort study (Global Gynaecological Oncology Surgical Outcomes Collaborative). Int J Gynecol Cancer. 2022 Dec 5;32(12):1606-1610. doi: 10.1136/ijgc-2022-004101.

    PMID: 36379595DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Faiza Gaba

CONTACT

+442035942053faiza.gaba1@abdn.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 31, 2022

Study Start

August 26, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations

GB(1)