The INFLUENCE of Cytoreduction on PRO in EOC

Study Overview
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Brief Summary
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Based on an improved understanding of how the extent of successful cytoreduction is influenced both by inherent tumor biological characteristics as well as the aggressiveness of the surgical approach this project aims to better define the value of cytoreduction and to use the knowledge gained to develop more individualized therapy and follow-up. This will be achieved through a translational biomedical research approach. Due to the research group's traditions clinical phenotyping, biomarker identification, and clinical trials will be the focus.

Detailed Description
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The patients will be recruited at their follow-up appointment after their surgery. At this consultation the patient will be informed about the final diagnosis and extent of disease and a plan for their further chemotherapeutic treatment will be developed. All patients will be offered carboplatin AUC 5 and paclitaxel 175mg/m2 q3w for 6 cycles [+ bevacizumab 7.5mg/kg q3w for 18 cycles in high-risk women of recurrence (IIIc not maximal debulked with a rest tumor of >1 cm2 and stage IV)]. In they fulfill the inclusion criteria and agree the inform consent formula will be signed. During the screening period the study team will secure that the necessary information needed is available and study specific test and analysis will be undertaken. After inclusion the study specific consultations will be scheduled coinciding with the patient regular appointments for treatment and follow-up. The patients will be followed at predetermined time points (after finalizing the chemotherapy; and every 3 months thereafter for 2 years).

Official Title
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The INFLUENCE of Cytoreduction on Patient Reported Outcomes in Patients With Epithelial Ovarian Cancer

Conditions
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Epithelial Ovarian Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epithelial ovarian cancer Stage > II ECOG < II Treated with primary surgery followed by chemotherapy Willing to participate and to sign the informed consent Exclusion Criteria: < 18 years old Borderline and non-epithelial ovarian tumors Stage < II Advanced ovarian cancer submitted to neoadjuvant chemotherapy ECOG 3-4 Pregnancy Severe cardiopulmonary disease Patients participating in QoL intervention studies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epithelial ovarial cancer<br>Patients primary treated with primary surgery for advanced epithelial ovarian cancer (> stage IIa) at the participating institutions will be asked to participate. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Global Health Score | Is there a relationship between QOL score and immunologic profiling in biological samples? | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epithelial ovarian cancer, Surgery, Quality of life