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This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be collected during up to 15 months of treatment and 12 months of follow-up. A second recruitment phase has been opened to focus on patients >/= 70 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Overall sample | ||
| Subgroup | Patients aged >/= 70 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Progression-free survival | up to approximately 27 months | |
| Safety: Incidence of adverse events | approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires | up to approximately 27 months | |
| Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer with indication for first-line carboplatin/paclitaxel chemotherapy in combination with Avastin. In the second study phase recruitment focusses on patients >/= 70 years.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ortenau Klinikum Offenburg; Med. Klinik II; Mammachirurgie und Gynäkologisch-Onkologische Chirurgie | Offenburg | 77652 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34638225 | Derived | Sehouli J, Mustea A, Oskay-Ozcelik G, Keller M, Richter R, Tome O, Woopen H, Sommer-Joos AK, Grabowski JP, Armbrust R, Wimberger P. Bevacizumab Combined with Platinum-Taxane Chemotherapy as First-Line Treatment for Advanced Ovarian Cancer: Results of the NOGGO Non-Interventional Study (OTILIA) in 824 Patients. Cancers (Basel). 2021 Sep 22;13(19):4739. doi: 10.3390/cancers13194739. |
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| approximately 5 years |
| Treatment discontinuations/modifications | approximately 5 years |
| Treatment duration | approximately 5 years |
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
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