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

Study Overview
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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.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Procedure: interval cytoreductive surgery
* Procedure: delayed cytoreductive surgery
* Other: no surgery


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| interval cytoreductive surgery<br>women with stage III-IV ovarian cancer, undergoing interval (after 3-4 cycles of chemotherapy) cytoreductive surgery | Procedure: interval cytoreductive surgery<br>* cytoreductive surgery after 3-4 cycles of chemotherapy<br>|
| delayed cytoreductive surgery<br>women with stage III-IV ovarian cancer, undergoing delayed (>5 cycles of chemotherapy) cytoreductive surgery | Procedure: delayed cytoreductive surgery<br>* surgery after >5 cycles of chemotherapy<br>|
| no surgery<br>women with stage III-IV ovarian cancer, undergoing >5 cycles of chemotherapy alone (no cytoreductive surgery) | Other: no surgery<br>* no cytoreductive surgery (>5 cycles of chemotherapy alone)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | defined from date of diagnosis to date of death by any cause or loss to follow-up | 15 years | 
| progression free survival | defined from date of diagnosis to date of first recurrence | 15 years | 
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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survival, morbidity, cytoreduction, disparities