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Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer

NCT ID: NCT05523804

Last Updated: 2022-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-26

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Keywords

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survival morbidity cytoreduction disparities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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interval cytoreductive surgery

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

interval cytoreductive surgery

Intervention Type PROCEDURE

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

delayed cytoreductive surgery

Intervention Type PROCEDURE

surgery after \>5 cycles of chemotherapy

no surgery

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

no surgery

Intervention Type OTHER

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

Interventions

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interval cytoreductive surgery

cytoreductive surgery after 3-4 cycles of chemotherapy

Intervention Type PROCEDURE

delayed cytoreductive surgery

surgery after \>5 cycles of chemotherapy

Intervention Type PROCEDURE

no surgery

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aberdeen

OTHER

Sponsor Role collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role collaborator

Queen Mary University of London

OTHER

Sponsor Role collaborator

NHS Grampian

OTHER_GOV

Sponsor Role lead

Responsible Party

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Faiza Gaba

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Royal London Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Faiza Gaba

Role: CONTACT

Phone: +442035942053

Email: [email protected]

Facility Contacts

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Faiza Gaba

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36379595 (View on PubMed)

Other Identifiers

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5719

Identifier Type: -

Identifier Source: org_study_id