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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01697488
Other study ID # ML27765
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2012
Est. completion date September 27, 2019

Study information

Verified date October 2019
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1090
Est. completion date September 27, 2019
Est. primary completion date September 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Ortenau Klinikum Offenburg; Med. Klinik II; Mammachirurgie und Gynäkologisch-Onkologische Chirurgie Offenburg

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy: Progression-free survival up to approximately 27 months
Primary Safety: Incidence of adverse events approximately 5 years
Secondary Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires up to approximately 27 months
Secondary Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics approximately 5 years
Secondary Treatment discontinuations/modifications approximately 5 years
Secondary Treatment duration approximately 5 years
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