Ovarian Cancer
Conditions
Keywords
Ovarian Cancer, Chemotherapy, Anti-angiogenic agent, Bevacizumab, Front Line
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.
Interventions
None listed
Sponsors
Hellenic Oncology Research Group
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | Every 3 weeks up to 18 weeks | In this observational study investigators are going to assess standard schedules in which administration was every 3 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Response Rate | Disease evaluation at Week 3 | In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 weeks |
| Percentage of Patients with Progression Free Survival | 1 year | — |
| Patients Overall Survival | 1 year | — |
Countries
Greece
Outcome results
None listed