Ovarian Cancer
Conditions
Keywords
survival, morbidity, cytoreduction, disparities
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.
Interventions
PROCEDUREinterval cytoreductive surgery
cytoreductive surgery after 3-4 cycles of chemotherapy
PROCEDUREdelayed cytoreductive surgery
surgery after \>5 cycles of chemotherapy
OTHERno surgery
no cytoreductive surgery (\>5 cycles of chemotherapy alone)
Sponsors
University of Aberdeen
Barts & The London NHS Trust
Queen Mary University of London
NHS Grampian
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 15 years | defined from date of diagnosis to date of death by any cause or loss to follow-up |
| progression free survival | 15 years | defined from date of diagnosis to date of first recurrence |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative morbidity | within 30 days from date of surgery | as per Clavien-Dindo classification |
| Resectability rates | at time of surgery | R0 = no visible disease, R1 = \<10mm visible residual disease, R2 = \>10mm visible residual disease |
Countries
United Kingdom
Contacts
Primary ContactFaiza Gaba
Outcome results
None listed