An Observational Study of Avastin (Bevacizumab) in Combination With Carboplatin/Paclitaxel in First Line in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OTILIA)
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ClinicalTrials.gov Identifier: NCT01697488 |
Recruitment Status :
Completed
First Posted : October 2, 2012
Last Update Posted : October 8, 2019
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Condition or disease |
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Peritoneal Neoplasms |
Study Type : | Observational |
Actual Enrollment : | 1090 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Non-interventional Surveillance Study (NIS) on First-line (FL) Bevacizumab (Avastin) in Combination With Carboplatin/Paclitaxel in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
Actual Study Start Date : | February 2, 2012 |
Actual Primary Completion Date : | September 27, 2019 |
Actual Study Completion Date : | September 27, 2019 |
Group/Cohort |
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Cohort
Overall sample
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Subgroup
Patients aged >/= 70 years
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- Efficacy: Progression-free survival [ Time Frame: up to approximately 27 months ]
- Safety: Incidence of adverse events [ Time Frame: approximately 5 years ]
- Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires [ Time Frame: up to approximately 27 months ]
- Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics [ Time Frame: approximately 5 years ]
- Treatment discontinuations/modifications [ Time Frame: approximately 5 years ]
- Treatment duration [ Time Frame: approximately 5 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Study phase 1: Patients aged >/= 18 years
- Study phase 2: Patients aged >/= 70 years
- Newly diagnosed advanced epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer with indication for a first-line carboplatin/paclitaxel chemotherapy in combination with Avastin
Exclusion Criteria:
- Contraindications to Avastin according to Summary of Product Characteristics

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697488
Germany | |
Ortenau Klinikum Offenburg; Med. Klinik II; Mammachirurgie und Gynäkologisch-Onkologische Chirurgie | |
Offenburg, Germany, 77652 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01697488 |
Other Study ID Numbers: |
ML27765 |
First Posted: | October 2, 2012 Key Record Dates |
Last Update Posted: | October 8, 2019 |
Last Verified: | October 2019 |
Peritoneal Neoplasms Abdominal Neoplasms Neoplasms by Site Neoplasms |
Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases |