Observation of Bevacizumab Plus Front-line Chemotherapy in Patients With Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events) of bevacizumab (Avastin) when added to chemotherapy as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma

Detailed Description
-----------------
In the last decade, clinical studies with bevacizumab (Avastin) in various tumors have shown encouraging results in terms of efficacy/safety. However there is no data generated in Greek population with regards to safety and efficacy of bevacizumab in front line Ovarian Cancer. Two prior global phase III randomized trials showed that the addition of concurrent bevacizumab to standard chemotherapy and maintenance bevacizumab significantly increased the PFS in patients with advanced ovarian cancer It would be relevant to document the real life clinical data of bevacizumab in combination with chemotherapy (paclitaxel/carboplatin) in Front Line Ovarian Cancer as prescribed by the medical oncologists in Greece.

Official Title
-----------------
A Multicentre, Observational Study of Bevacizumab (Avastin) Added to Front-line Chemotherapy in Patients With Stage IIIb, IIIC or IV Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma in Routine Clinical Practice.

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Age ≥18 years Histologically confirmed advanced stage III (suboptimally debulked >1cm of residual disease) or stage IV ovarian cancer fallopian tube carcinoma or primary peritoneal cancer following surgical debulking with the aim of maximal surgical cytoreduction One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria ECOG performance status ≤2 Adequate haematological, renal and hepatic function Urine protein <2+ (dipstick) Life expectancy of >12 weeks Exclusion Criteria: Previous front line treatment for ovarina cancer Previous radiotherapy to target lesions Patients with brain metastases and/or cancerous meningitis Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma Patients participating in interventional clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Avastin regimens<br>Patients who are going to receive chemotherapy plus Avastin (bevacizumab) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | In this observational study investigators are going to assess standard schedules in which administration was every 3 weeks | Every 3 weeks up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Response Rate | In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 weeks | Disease evaluation at Week 3 | 
| Percentage of Patients with Progression Free Survival |  | 1 year | 
| Patients Overall Survival |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ovarian Cancer, Chemotherapy, Anti-angiogenic agent, Bevacizumab, Front Line