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Trial Title:
Patient Outcomes Following Interval and Delayed Cytoreductive Surgery in Advanced Ovarian Cancer
NCT ID:
NCT05523804
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
survival
morbidity
cytoreduction
disparities
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
interval cytoreductive surgery
Description:
cytoreductive surgery after 3-4 cycles of chemotherapy
Arm group label:
interval cytoreductive surgery
Intervention type:
Procedure
Intervention name:
delayed cytoreductive surgery
Description:
surgery after >5 cycles of chemotherapy
Arm group label:
delayed cytoreductive surgery
Intervention type:
Other
Intervention name:
no surgery
Description:
no cytoreductive surgery (>5 cycles of chemotherapy alone)
Arm group label:
no surgery
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.
Criteria for eligibility:
Study pop:
women with stage III-IV ovarian cancer
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Royal London Hospital
Address:
City:
London
Zip:
E1 1FR
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Faiza Gaba
Phone:
+442035942053
Email:
faiza.gaba1@abdn.ac.uk
Start date:
August 26, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
NHS Grampian
Agency class:
Other
Collaborator:
Agency:
University of Aberdeen
Agency class:
Other
Collaborator:
Agency:
Barts & The London NHS Trust
Agency class:
Other
Collaborator:
Agency:
Queen Mary University of London
Agency class:
Other
Source:
NHS Grampian
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05523804
