Secondary Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancers

Study Overview
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Brief Summary
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This novel study was specifically designed for platinum resistant recurrent ovarian cancers and aimed to compare cases who received secondary cytoreductive surgery for isolated recurrence and chemotherapy versus chemotherapy alone. This comparison will conduct the intraoperative events, postoperative morbidity and mortality, pathological outcomes and long-term oncological outcomes as regarding progression free survival and overall survival rates.

Detailed Description
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Baseline postoperative imaging with the use of abdominopelvic CT or MRI was to be completed during a 28-day window in which chemotherapy was initiated. Disease is also assessed after cycles 3 and 6 of trial treatment (and after cycle 8, if administered), every 3 months for 2 years, and then every 6 months thereafter. Physical examinations will be performed, and serum CA-125 levels measured at the beginning of each cycle of chemotherapy. Treatment-free interval (6 to 12 months or >12 months after the last chemotherapy infusion) will be reported.

Official Title
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Clinical Outcomes of Secondary Cytoreductive Surgery in Platinum-resistant Ovarian Cancers With Isolated Recurrence

Conditions
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Ovarian Cancer, Recurrent Ovarian Carcinoma

Intervention / Treatment
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* Procedure: secondary cytoreductive surgery
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: platinum-resistant, recurrent epithelial ovarian cancer amenable to complete gross resection, isolated recurrence adequate renal, hepatic, and bone marrow function, performance-status ECOG score of 0 to 2. Exclusion Criteria: not medically fit for surgery diffuse carcinomatosis, ascites, or extra-abdominal disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients with platinum resistant cancer ovary will be randomized to one of two arms; either chemotherapy alone or surgical resection followed by chemotherapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery + chemotherapy<br>surgical resection for recurrent platinum resistant ovarian cancer followed by second line chemotherapy as per the investigator's choice | Procedure: secondary cytoreductive surgery<br>* resection of isolated recurrent ovarian carcinoma in platinum resistant disease<br>* Other names: re-resection;Drug: Chemotherapy<br>* second line chemotherapy according to investigator's choice<br>|
| Active Comparator: chemotherapy alone<br>second line chemotherapy according to investigator's choice | Drug: Chemotherapy<br>* second line chemotherapy according to investigator's choice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival (PFS) | the time interval between the first relapse and the second relapse | 6 months from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | the time interval between the date of diagnosis till the date of death | 18 months from enrollment | 
| Adverse events (AE) | described according to the CTCAE | 6 months from enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer, platinum resistant, cytoreductive surgery, recurrent ovarian cancer, complete resection