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

Ovarian Cancer Clinical Trial

— GO SOAR2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05523804
• Other study ID #: 5719
• Status: Recruiting
• Start date: August 26, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: NHS Grampian
• Contact: Faiza Gaba
• Phone: +442035942053
• Email: faiza.gaba1[@]abdn.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• interval cytoreductive surgery
cytoreductive surgery after 3-4 cycles of chemotherapy
• delayed cytoreductive surgery
surgery after >5 cycles of chemotherapy

Other:
• no surgery
no cytoreductive surgery (>5 cycles of chemotherapy alone)

Locations

Country	Name	City	State
United Kingdom	The Royal London Hospital	London

Sponsors (4)

Lead Sponsor	Collaborator
NHS Grampian	Barts & The London NHS Trust, Queen Mary University of London, University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	defined from date of diagnosis to date of death by any cause or loss to follow-up	15 years
Primary	progression free survival	defined from date of diagnosis to date of first recurrence	15 years
Primary	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	Post-operative morbidity	as per Clavien-Dindo classification	within 30 days from date of surgery
Secondary	Resectability rates	R0 = no visible disease, R1 = <10mm visible residual disease, R2 = >10mm visible residual disease	at time of surgery