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)

NCT ID: NCT01697488

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1090 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-02

Study Completion Date

2019-09-27

Brief Summary

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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.

Detailed Description

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Conditions

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Peritoneal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

Overall sample

No interventions assigned to this group

Subgroup

Patients aged \>/= 70 years

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Ortenau Klinikum Offenburg; Med. Klinik II; Mammachirurgie und Gynäkologisch-Onkologische Chirurgie

Offenburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 34638225 (View on PubMed)

Other Identifiers

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ML27765

Identifier Type: -

Identifier Source: org_study_id

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