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

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Other: no surgery; Procedure: delayed cytoreductive surgery; Procedure: interval cytoreductive surgery

• Registration Number: NCT05523804
• Lead Sponsor: NHS Grampian

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.

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 Timeline

• Status Verified: 2022-08
• Study Start: 2022-08-26
• Study First Submitted: 2022-08-26
• Study First Submitted QC: 2022-08-30
• Last Update Submitted: 2022-08-30
• Study First Posted: 2022-08-31
• Last Update Posted: 2022-08-31
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no surgery	no surgery	women with stage III-IV ovarian cancer, undergoing \>5 cycles of chemotherapy alone (no cytoreductive surgery)
delayed cytoreductive surgery	delayed cytoreductive surgery	women with stage III-IV ovarian cancer, undergoing delayed (\>5 cycles of chemotherapy) cytoreductive surgery
interval cytoreductive surgery	interval cytoreductive surgery	women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) cytoreductive surgery

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Royal London Hospital; 🇬🇧 London, United Kingdom